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(b) Indications. The labeling of the product states, under the heading "Indications," one or more of the following phrases:

(1) “For the temporary relief of burning and irritation due to dryness of the eye."

(2) “For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun."

(3) "For use as a protectant against further irritation or to relieve dryness of the eye.

(4) “For use as a lubricant to prevent further irritation or to relieve dryness of the eye."

(c) Warnings. In addition to the warnings in 8 349.50, the labeling of the product contains the following warnings under the heading "Warnings" for products containing any ingredient identified in 8 349.12:

(1) "If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor."

(2) "If solution changes color or becomes cloudy, do not use."

(d) Directions. The labeling of the product contains the following information under the heading "Directions”': Instill 1 or 2 drops in the affected eye(s) as needed.

(4) “For use as a lubricant to prevent further irritation or to relieve dryness of the eye."

(c) Warnings. In addition to the warnings in $ 349.50, the labeling of the product contains the following warnings under the heading “Warnings" for products containing any

any ingredient identified in $349.14: "If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor."

(d) Directions. The labeling of the product contains the following information under the heading "Directions": Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

8349.65 Labeling of ophthalmic emol

lient drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug(s), if any, and identifies the product as a “lubricant" or "emollient (lubricant)" (select one of the following: "eye" or "ophthalmic") "(insert dosage form, e.g., ointment).”

(b) Indications. The labeling of the product states, under the heading “Indications," one or more of the following phrases:

(1) “For the temporary relief of burning and irritation due to dryness of the eye."

(2) “For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

(3) "For use as a protectant against further irritation or to relieve dryness of the eye.”

$ 349.70 Labeling of ophthalmic

hypertonicity drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “hypertonicity” (select one of the following: "eye” or "ophthalmic") "(insert dosage form, e.g., drops)."

(b) Indications. The labeling of the product states, under the heading "Indications," the following phrase: “For the temporary relief of corneal edema."

(c) Warnings. In addition to the warnings in 8 349.50, the labeling of the product contains the following warnings under the heading “Warnings" for products containing any ingredient identified in $349.16:

(1) "Do not use this product except under the advice and supervision of a doctor. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor."

(2) “This product may cause temporary burning and irritation on being instilled into the eye."

(3) "If solution changes color or becomes cloudy, do not use."

(d) Directions. The labeling of the product contains the following information under the heading “Directions'': Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a doctor.

§ 349.75 Labeling of ophthalmic vaso

constrictor drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug(s), if any, and identifies the product as a "redness reliever" or "vasoconstrictor (redness reliever)" (select one of the following: "eye" or "ophthalmic'') "(insert dosage form, e.g., drops).”

(b) Indications. The labeling of the product states, under the heading "Indications,” the following phrase: “Relieves redness of the eye due to minor eye irritations."

(c) Warnings. In addition to the warnings in 8349.50, the labeling of the product contains the following warnings under the heading “Warnings" for products containing any ingredient identified in 8 349.18:

(1) “If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor."

(2) "If you have glaucoma, do not use this product except under the advice and supervision of a doctor."

(3) "Overuse of this product may produce increased redness of the eye."

(4) “If solution changes color or becomes cloudy, do not use."

(d) Directions. The labeling of the product contains the following information under the

under the heading “Directions'': Instill 1 to 2 drops in the affected eye(s) up to four times daily.

(2) "For” (select one of the following: “flushing," "irrigating," "cleansing, " "washing,” or “bathing'') "the eye to help relieve" (select one or more of the following: "irritation, "discomfort," "burning," "stinging, "smarting," or "itching”) "by removing" (select one or more of the following: “loose foreign material," "air pollutants (smog or pollen)," or "chlorinated water”).

(c) Warnings. In addition to the warnings in $349.50, the labeling of the product contains the following warnings under the heading “Warnings” for all eyewash products:

(1) "If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor."

(2) "Obtain immediate medical treatment for all open wounds in or near the eyes.

(3) “If solution changes color or becomes cloudy, do not use.

(d) Directions. The labeling of the product contains the following information under the heading "Directions":

(1) For eyewash products intended for use with an eyecup. Rinse cup with clean water immediately before each use. Avoid contamination of rim and inside surfaces of cup. Fill cup half full and apply the cup to the affected eye, pressing tightly to prevent the escape of the liquid, and tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash or lotion. Rinse cup with clean water after each use.

(2) For eyewash products intended for use with a nozzle applicator. Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

or

8 349.78 Labeling of eyewash drug

products. (a) Statement of identity. The labeling of the product identifies the product with one or more of the following terms: "eyewash,” "eye lotion," eye irrigating solution."

(b) Indications. The labeling of the product states, under the heading “Indications,

of the following phrases:

(1) “For" (select one of the following: “flushing," "irrigating," "cleansing, “washing," or "bathing”) “the eye to remove" (select one or more of the following: “loose foreign material," "air pollutants (smog

pollen)," “chlorinated water”').

one

$349.79 Labeling of permitted com

binations of active ingredients. Statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable.

(a) Statement of identity. For a combination drug product that has an established name, the labeling of the product states the established name of

or

or

355.20 Packaging conditions.

Subpart C-Labeling

355.50 Labeling of anticaries drug products. 355.55 Principal display panel of all fluoride

rinse drug products. 335.60 Professional labeling.

Subpart D-Testing Procedures

355.70 Testing procedures for fluoride den

tifrice drug products.

AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

SOURCE: 60 FR 52507, Oct. 6, 1995, unless otherwise noted.

Subpart A-General Provisions

the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of this part. For a combination drug product that does not have an established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of this part.

(b) Indications. The labeling of the product states, under the heading “Indications,” the indication(s) for each ingredient in the combination, as established in the indications sections of this part.

(c) Warnings. The labeling of the product states, under the heading “Warnings,” the warning(s) for each ingredient in the combination, as established in the warnings sections of this part.

(d) Directions. The labeling of the product states, under the heading “Directions," directions that conform to the directions established for each ingredient in the directions sections of this part. When the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not exceed any maximum dosage limits established for the individual ingredients in the applicable OTC drug monograph.

8355.1 Scope.

(a) An over-the-counter anticaries drug product in a form suitable for topical administration to the teeth is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in 8330.1 of this chapter.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

$ 349.80 Professional labeling.

The labeling of any OTC ophthalmic demulcent drug product provided to health professionals (but not to the general public) may contain instructions for the use of these products in professional eye examinations (i.e. gonioscopy, electroretinography).

8 355.3 Definitions.

As used in this part:

(a) Abrasive. Solid materials that are added to dentifrices to facilitate mechanical removal of dental plaque, debris, and stain from tooth surfaces.

(b) Anhydrous glycerin. An ingredient that may be prepared by heating glycerin U.S.P. at 150 -C for 2 hours to drive off the moisture content.

(c) Anticaries drug. A drug that aids in the prevention and prophylactic treatment of dental cavities (decay, caries).

(d) Dental caries. A disease of calcified tissues of teeth characterized by demineralization of the inorganic portion and destruction of the organic matrix.

(e) Dentifrice. An abrasive-containing dosage form (gel, paste, or powder) for delivering an anticaries drug to the teeth.

(f) Fluoride. The inorganic form of the chemical element fluorine in combination with other elements.

PART 355—ANTICARIES DRUG

PRODUCTS FOR OVER-THE-
COUNTER HUMAN USE

Subpart A-General Provisions

Sec. 355.1 Scope. 355.3 Definitions.

Subpart B-Active Ingredients

355.10 Anticaries active ingredients.

(g) Fluoride

ion. The negatively charged atom of the chemical element fluorine.

(h) Fluoride supplement. A special treatment rinse dosage form that is intended to be swallowed, and is promoted to health professionals for use in areas where the water supply contains 0 to 0.7 parts per million (ppm) fluoride ion.

(i) Preventive treatment gel. A dosage form for delivering an anticaries drug to the teeth. Preventive treatment gels are formulated in an anhydrous glycerin base with suitable thickening agents included to adjust viscosity. Preventive treatment gels do not contain abrasives.

(j) Treatment rinse. A liquid dosage form for delivering an anticaries drug to the teeth.

(k) Treatment rinse concentrated solution. A fluoride treatment rinse in a concentrated form to be mixed with water before using to result in the appropriate fluoride concentration specified in the monograph.

(1) Treatment rinse effervescent tablets. A fluoride treatment rinse prepared by adding an effervescent tablet (a concentrated solid dosage form) to water before using to result in the appropriate fluoride concentration specified in the monograph.

(m) Treatment rinse powder. A fluoride treatment rinse prepared by adding the powder (a concentrated solid dosage form) to water before using to result in the appropriate fluoride concentration specified in the monograph.

to 0.254 percent with an available fluoride ion concentration of 2 850 ppm for products containing the abrasive 50dium bicarbonate and a poured-bulk density of 1.0 to 1.2 grams per milliliter.

(3) Treatment rinses. (i) An aqueous solution of acidulated phosphate fluoride derived from sodium fluoride acidulated with a mixture of sodium phosphate, monobasic, and phosphoric acid to a level of 0.1 molar phosphate ion and a pH of 3.0 to 4.5 and which yields an effective fluoride ion concentration of 0.02 percent.

(ii) An aqueous solution of acidulated phosphate fluoride derived from SOdium fluoride acidulated with a mixture of sodium phosphate, dibasic, and phosphoric acid to a pH of 3.5 and which yields an effective fluoride ion concentration of 0.01 percent.

(iii) Sodium fluoride 0.02 percent aqueous solution with a pH of approximateiy 7.

(iv) Sodium fluoride 0.05 percent aqueous solution with a pH of approximately 7.

(v) Sodium fluoride concentrate containing adequate directions for mixing with water before using to result in a 0.02-percent or 0.05-percent aqueous solution with a pH of approximately 7.

(b) Sodium monofluorophosphate (1) Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form. Sodium monofluorophosphate 0.654 to 0.884 percent with an available fluoride ion concentration (consisting of PO3 F= and F- combined) 2 800 ppm.

(2) Dentifrices containing 1,500 ppm theoretical total fluorine in a gel or paste dosage form. Sodium monofluorophosphate 1.153 percent with an available fluoride ion concentration (consisting of PO3 F= and F- combined) > 1,275 ppm.

(c) Stannous fluoride-(1) Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form. (i) Stannous fluoride 0.351 to 0.474 percent with an available fluoride ion concentration > 700 ppm for products containing abrasives other than calcium pyrophosphate.

(ii) Stannous fluoride 0.351 to 0.474 percent with an available fluoride ion concentration > 290 ppm for products

[CO FR 52507, Oct. 6, 1995, as amended at 61 FR 52286, Oct. 7, 1996)

Subpart B-Active ingredients

$ 355.10 Anticaries active ingredients.

The active ingredient of the product consists of any of the following when used in the concentration and dosage form established for each ingredient:

(a) Sodium fluoride (1) Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form. Sodium fluoride 0.188 to 0.254 percent with an available fluoride ion concentration > 650 parts per million (ppm).

(2) Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a powdered dosage form. Sodium fluoride 0.188

containing the abrasive calcium pyrophosphate.

(2) Preventive treatment gel. Stannous fluoride 0.4 percent in an anhydrous glycerin gel, made from anhydrous glycerin and the addition of suitable thickening agents to adjust viscosity.

(3) Treatment rinse. Stannous fluoride concentrate marketed in a stable form and containing adequate directions for mixing with water immediately before using to result in a 0.1-percent aqueous solution.

[60 FR 52507, Oct. 6, 1995, as amended at 61 FR 52286, Oct. 7, 1996)

$ 355.20 Packaging conditions.

(a) Package size limitation. Due to the toxicity associated with fluoride active ingredients, the following package size limitations are required for anticaries drug products:

(1) Dentifrices. Dentifrice (toothpastes and tooth powders) packages shall not contain more than 276 milligrams (mg) total fluorine per package.

(2) Preventive treatment gels and treatment rinses. Preventive treatment gel and treatment rinse packages shall not contain more than 120 mg total fluorine per package.

(3) Exception. Package size limitations do not apply to anticaries drug products marketed for professional office use only and labeled in accord with $ 355.60.

(b) Tight container packaging. To minimize moisture contamination, all fluoride powdered dentifrices shall be packaged in a tight container as defined as a container that protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight reclosure.

priate: “dentifrice," “toothpaste," “tooth polish," "tooth powder;" (optional: "dental”) "preventive treatment gel;” or (optional: "treatment" or “dental")) (select one of the following: “rinse," "concentrated solution," “rinse powder," or "rinse effervescent tablets”). The word "mouthwash" may be substituted for the word "rinse" in this statement of identity if the product also has a cosmetic use, as defined in section 201(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(i)).

(b) Indication. The labeling of the product states, under the heading “Indication,” the following: “Aids in the prevention of dental (select one of the following: "cavities," "decay," "caries (decay)," or "caries (cavities)”'). Other truthful and nonmisleading statements, describing only the indication for use that has been established and listed in this paragraph (b), may also be used, as provided in $330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(c) Warning. The labeling of the product contains the following warning under the heading “Warning":

(1) For all fluoride dentifrice (gel, paste, and powder) products. “Keep out of the reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.” These warnings shall be used in place of the general warning statements required $ 330.1(g) of this chapter.

(2) For all fluoride rinse and preventive treatment gel products. Keep this and all drugs out of the reach of children. If you accidentally swallow more than used for" (select appropriate word: “brushing" or "rinsing''), “seek professional assistance or contact a Poison Control Center immediately." These warnings shall be used in place of the general warning statements required by $330.1(g) of this chapter.

by

2

Subpart C-Labeling

355.50 Labeling of anticaries drug

products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as: (select one or both of the following: 'anticavity' or 'fluoride') (select one of the following as appro

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