Lapas attēli
PDF
ePub

(iv) FOT products

containing oxymetazoline hydrochloride identified in $341.2006)(7)(A) Nasal drops or sprays(1) For a 0.05-percent aqueous solution. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor.

(2) A 0.025-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.027 milligrams of oxymetazoline per three drops or three sprays. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour period. [previous two sentences in boldface type] Children under 2 years of age: consult a doctor.

(B) Nasal jellyFor a 0.05-percent water-based jelly. Adults and children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor.

(v) For products containing phenylephrine hydrochloride identified in § 341.2010)(8)(A) Nasal drops or sprays (1) For a 1-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.

(2) For a 0.5-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.

(3) For a 0.25-percent aqueous solution. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Children under 6 years of age: consult a doctor.

(4) A 0.125-percent aqueous solution in a container having either a calibrated

dropper or a metered-dose spray that delivers no more than 0.135 milligrams of phenylephrine per three drops or three sprays. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Use only recommended amount. [previous sentence in boldface type] Children under 2 years of age: consult a doctor.

(B) Nasal jelly--(1) For a 1-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.

(2) For a 0.5-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.

(3) For a 0.25-percent water-based jelly. Adults and children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours. Children under 6 years of age: consult a doctor.

(vi) For products containing propylhexedrine identified in $341.20(6)(9) when used in an inhalant dosage form. The product delivers in each 800 milliliters of air 0.40 to 0.50 milligrams of propylhexedrine. Adults and children 6 to under 12 years of age (with adult supervision): 2 inhalations in each nostril not more often than every 2 hours. Children under 6 years of age: consult a doctor.

(vii) For products containing xylometazoline hydrochloride identified in $ 341.2006)(10)(A) Nasal drops OT sprays—(1) For a 0.1-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 8 to 10 hours. Do not give to children under 12 years of age unless directed by a doctor.

(2) A 0.05-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.054 milligrams of xylometazoline per three drops or three sprays. Children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 8 to 10 hours. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 8 to 10 hours. Use only recommended amount. Do not exceed 3 doses in any 24-hour period. [previous two sentences in boldface type] Children under 2 years of age: consult a doctor.

(B) Nasal jelly_(1) For a 0.1-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 8 to 10 hours. Do not give to children under 12 years of age unless directed by a doctor.

(2) For a 0.05-percent water-based jelly. Children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 8 to 10 hours. Children under 6 years of age: consult a doctor.

(viii) Other required statements-For products containing

propylhexedrine identified in 8 341.20(b)(9) when used in an inhalant dosage form. (A) "This inhaler is effective for a minimum of 3 months after first use."

(B) "Keep inhaler tightly closed."

(b) For products containing chlophedianol hydrochloride identified in 341.14(a)(1). Children 2 to under 6 years of age: oral dosage is 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours.

(c) For products containing codeine ingredients identified in § 341.14(a)(2). (1) Children 2 to under 6 years of age: Oral dosage is 1 milligram per kilogram body weight per day administered in four equal divided doses. The average body weight for each age may also be used to determine dosage as follows: For children 2 years of age (average body weight, 12 kilograms), the oral dosage is 3 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours; for children 3 years of age (average body weight, 14 kilograms), the oral dosage is 3.5 milligrams every 4 to 6 hours, not to exceed 14 milligrams in 24 hours; for children 4 years of age (average body weight, 16 kilograms), the oral dosage is 4 milligrams every 4 to 6 hours, not to exceed 16 milligrams in 24 hours: for children 5 years of age (average body weight, 18 kilograms), the oral dosage is 4.5 milligrams every 4 to 6 hours, not to exceed 18 milligrams in 24 hours. The manufacturer must relate these dosages for its specific product dosages for its specific product to the use of the calibrated measuring device discussed in paragraph (c)(3) of this section. If age is used to determine the dose, the directions must include instructions to reduce the dose for lowweight children.

(2) Parents should be instructed to obtain and use a calibrated measuring device for administering the drug to the child, to use extreme care in measuring the dosage, and not exceed the recommended daily dosage.

(3) A dispensing device (such as a dropper calibrated for age or weight) should be dispensed along with the product when it is intended for use in children 2 to under 6 years of age to prevent possible overdose due to improper measuring of the dose.

(4) Codeine is not recommended for use in children under 2 years of age. Children under 2 years may be more susceptible to the respiratory depressant effects of codeine, including respiratory arrest, coma, and death.

[59 FR 43409, Aug. 23, 1994)

$ 341.90 Professional labeling.

The labeling of the product provided to health professionals (but not to the general public) may contain the following additional dosage information for products containing the active ingredients identified below:

(a) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in $ 341.16 (a), (b), (c), and (f). Children 6 to under 12 years of age: oral dosage is 6.25 to 12.5 milligrams every 4 hours, not to exceed 75 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 0.3 to 0.5 milligram per kilogram of body weight every 4 hours, not to exceed 2 milligrams per kilogram of body weight in 24 hours.

(d) The following labeling indication may be used for products containing guaifenesin identified in 8 341.18 when used as a single ingredient product. "Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis. (e) For

products

containing brompheniramine maleate identified in $ 341.12(a). Children 2 to under 6 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours. (f) For products

containing chlorcyclizine hydrochloride identified in $ 341.12(b). Children 6 to under 12 years of age: oral dosage is 12.5 milligrams every 6 to 8 hours, not to exceed 37.5 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 6 to 8 hours, not to exceed 18.75 milligrams in 24 hours.

For products containing chlorpheniramine maleate identified in $ 341.12(c). Children 2 to under 6 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours.

(h) For products containing dexbrompheniramine maleate identified in $ 341.12(d). Children 2 to under 6 years of age: oral dosage is 0.5 milligram every 4 to 6 hours, not to exceed 3 milligrams in 24 hours.

(i) For products containing dexchlorpheniramine maleate identified in $ 341.12(e). Children 2 to under 6 years: oral dosage is 0.5 milligram every 4 to 6 hours, not to exceed 3 milligrams in 24 hours.

(j) For products containing diphenhydramine citrate identified in $ 341.12(f). Children 2 to under 6 years of age: oral dosage is 9.5 milligrams every 4 to 6 hours, not to exceed 57 milligrams in 24 hours. (k) For products

containing diphenhydramine hydrochloride identified in $ 341.12(g). Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 mg in 24 hours.

(1) For products containing doxylamine succinate identified in $341.12(h). Children 2 to under 6 years of age: oral dosage is 1.9 to 3.125 milligrams every 4 to

6 hours, not to exceed 18.75 milligrams in 24 hours.

(m) For products containing phenindamine tartrate identified in $ 341.12(i). Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours.

(n) For products containing pheniramine maleate identified in $ 341.12(1). Children 2 to under 6 years of age: oral dosage is 3.125 to 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours.

(0) For products containing pyrilamine maleate identified in $341.12(k). Children 2 to under 6 years of age: oral dosage is 6.25 to 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours.

(p) For products containing thonzylamine hydrochloride identified in $ 341.12(1). Children 2 to under 6 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours.

(q) For products containing triprolidine hydrochloride identified in $341.12(m). Children 4 to under 6 years of age: oral dosage is 0.938 milligram every 4 to 6 hours, not to exceed 3.744 milligrams in 24 hours. Children 2 to under 4 years of age: oral dosage is 0.625 milligram every 4 to 6 hours, not to exceed 2.5 milligrams in 24 hours. Infants 4 months to under 2 years of age: oral dosage is 0.313 milligram every 4 to 6 hours, not to exceed 1.252 milligrams in 24 hours.

(r) For products containing diphenhydramine citrate identified in $ 341.14(a)(5). Children 2 to under 6 years of age: oral dosage is 9.5 milligrams every 4 hours, not to exceed 57 milligrams in 24 hours.

(s) For products containing diphenhydramine hydrochloride identified in $ 341.14(a)(6). Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 4 hours, not to exceed 37.5 milligrams in 24 hours.

(51 FR 35339, Oct. 2, 1986, as amended at 52 FR 30057, Aug. 12, 1987; 54 FR 8509, Feb. 28, 1989; 57 FR 58376, Dec. 9, 1992; 59 FR 4218, Jan. 28, 1994; 59 FR 29174, June 3, 1994; 59 FR 36051, July 15, 1994]

[blocks in formation]

Subpart C-Labeling $344.50 Labeling of topical otic 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 an "earwax removal aid."

(b) Indication. The labeling of the product states, under the heading “Indication,” the following: “For occasional use as an aid to" (which may be followed by: “soften, loosen, and") “remove excessive earwax." Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in $330.1(c)(2), subject to the provisions of section 502 of 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) Warnings. The labeling of the product contains the following warnings under the heading "Warnings":

(1) “Do not use if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor."

(2) “Do not use if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor.''

(3) “Do not use for more than 4 days; if excessive earwax remains after use of this product, consult a doctor."

(4) “Avoid contact with the eyes.

(d) Directions. The labeling of the product contains the following statement under the heading “Directions": FOR USE IN THE EAR ONLY. Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age: consult a doctor.

8 344.3 Definitions.

As used in this part:

(a) 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.

(b) Earwax removal aid. A drug used in the external ear canal that aids in the removal of excessive earwax.

Subpart B-Active Ingredients

8344.10 Topical otic active ingredient.

The active ingredient of the product consists of carbamide peroxide 6.5 percent formulated in an anhydrous glycerin vehicle.

(e) Optional wording. The word "physician" may be substituted for the word "doctor" in any of the labeling statements in this section.

[51 FR 28660, Aug. 8, 1986; 52 FR 7830, Mar. 13, 1987]

PART 346-ANORECTAL DRUG

PRODUCTS FOR OVER-THECOUNTER HUMAN USE

Subpart A-General Provisions

Sec. 346.1 Scope. 346.3 Definitions.

Subpart B-Active Ingredients

346.10 Local anesthetic active ingredients. 346.12 Vasoconstrictor active ingredients. 346.14 Protectant active ingredients. 346.16 Analgesic, anesthetic, and anti

pruritic active ingredients. 346.18 Astringent active ingredients. 346.20 Keratolytic active ingredients. 346.22 Permitted combinations of anorectal

active ingredients.

(b) Anorectal drug. A drug that is used to relieve symptoms caused by anorectal disorders in the anal canal, perianal area, and/or the lower rectal areas.

(c) Antipruritic drug. A topically (externally) applied drug that relieves itching by depressing cutaneous sensory receptors.

(d) Astringent drug. A drug that is applied topically (externally) to the skin or mucous membranes for a local and limited protein coagulant effect.

(e) External use. Topical application of an anorectal drug product to the skin of the perianal area and/or the skin of the anal canal.

(f) Intrarectal use. Topical application of an anorectal drug product to the mucous membrane of the rectum.

(g) Keratolytic drug. A drug that causes desquamation (loosening) and debridement or sloughing of the surface cells of the epidermis.

(h) Local anesthetic drug. A drug that produces local disappearance of pain, burning, itching, irritation, and/or discomfort by reversibly blocking nerve conduction when applied to nerve tissue in appropriate concentrations.

(i) Protectant drug. A drug that provides a physical barrier, forming a protective coating over skin or mucous membranes.

(j) Vasoconstrictor. A drug that causes temporary constriction of blood vessels.

Subpart C-Labeling

346.50 Labeling of anorectal drug products. 346.52 Labeling of permitted combinations

of anorectal active ingredients.

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

SOURCE: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.

Subpart A-General Provisions

Subpart B-Active Ingredients

$ 346.10 Local anesthetic active ingre

dients.

$ 346.1 Scope.

(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration 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 212 unless otherwise noted.

The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient:

(a) Benzocaine 5 to 20 percent.
(b) Benzyl alcohol 1 to 4 percent.
(c) Dibucaine 0.25 to 1 percent.

(a) Dibucaine hydrochloride 0.25 to 1 percent.

(e) Dyclonine hydrochloride 0.5 to 1 percent.

(f) Lidocaine 2 to 5 percent.

(g) Pramoxine hydrochloride 1 percent.

(h) Tetracaine 0.5 to 1 percent.

8 346.3 Definitions.

As used in this part:

(a) Analgesic, anesthetic drug. A topically (externally) applied drug that relieves pain by depressing cutaneous sensory receptors.

« iepriekšējāTurpināt »