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

(1) For anticaries dentifrice products(1) Gel or paste dosage form with a theoretical total fluorine concentration of 850 to 1,150 ppm identified in $ 355.10(a)(1), (b)(1), and (c)(1). Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

(ii) Gel or paste dosage form with a theoretical total fluorine concentration of 1,500 ppm identified

identified in $ 355.10(b)(2). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor.

(iii) Powdered dosage form with a theoretical total fluorine concentration of 850 to 1,150 ppm identified in $355,10(a)(2). Adults and children 6 years of age and older: Apply powder to a wet toothbrush; completely cover all bristles. Brush for at least 30 seconds. Reapply powder as before and

before and brush again. Rinse and spit out thoroughly. Brush teeth, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor.

(2) For anticaries treatment rinse products-(i) For acidulated phosphate fluoride solution containing 0.02 percent fluoride ion, sodium fluoride 0.05 percent, sodium fluoride concentrate, and stannous fluoride concentrate identified in

$ 355.10(a)(3)(i), (a)(3)(iv), (a)(3)(v), and (c)(3). Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

(ii) For acidulated phosphate fluoride solution containing 0.01 percent fluoride ion and sodium fluoride 0.02 percent aqueous solution identified in $ 355.10(a)(3)(ii) and (a)(3)(iii). Adults and children 6 years of age and older: Use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dentist or doctor.

(3) For stannous fluoride treatment rinse products. (i) "Use immediately after preparing the rinse."

(ii) For powder or effervescent tablets used to prepare treatment rinses. “Do not use as a rinse until all the” (select one of the following: “powder" or "tablet") “has dissolved."

(4) For anticaries preventive treatment gel products. Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dentist or doctor.

(5) For all concentrated treatment rinse solutions, powders, and effervescent tablets. The following statement shall appear as the first statement under directions: “Do not use before mixing with water."

(e) Additional labeling statements for anticaries drug products. The following statements need not appear under warnings, but are required to appear on the label of anticaries drugs products as applicable.

(1) For all preventive treatment gels. “This is a(n)” (select one or both of the following: “anticavity” or “fluoride”) "preventive treatment gel, not a toothpaste. Read directions carefully before using."

(2) For all stannous fluoride treatment rinse, preventive treatment gel, and dentifrice products. “This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist."

(f) Optional additional labeling statements—(1) For fluoride treatment rinses and preventive treatment gels. The following labeling statement may appear in the required boxed area designated “APPROVED USES": "The combined daily use of a fluoride preventive treatment” (select one of the following: "rinse" or "gel") "and a fluoride toothpaste can help reduce the incidence of dental cavities.”

(2) For dentifrice products containing 1,500 ppm theoretical total fluorine. “Adults and children over 6 years of age may wish to use this extrastrength fluoride dentifrice if they reside in a nonfluoridated area or if they have a greater tendency to develop cavities.'

8 355.60 Professional labeling.

(a) The labeling for anticaries fluoride treatment rinses identified in $355.10(a)(3) and (c)(3) that are specially formulated so they may be swallowed (fluoride supplements) and are provided to health professionals (but not to the general public) may contain the following additional dosage information: Children 3 to under 14 years of age: As a supplement in areas where the water supply is nonfluoridated (less than 0.3 parts per million (ppm)), clean the teeth with a toothpaste and rinse with 5 milliliters (mL) of 0.02 percent or 10 mL of 0.01 percent fluoride ion rinse daily, then swallow. When the water supply contains 0.3 to 0.7 ppm fluoride ion, reduce the dose to 2.5 mL of 0.02 percent or 5 mL of 0.01 percent fluoride ion rinse daily.

(b) The labeling for products marketed to health to health professionals in package sizes larger than those specified in $ 355.20 shall include the statements: "For Professional Office Use Only” and “This product is not intended for home or unsupervised consumer use."

Subpart D-Testing Procedures § 355.70 Testing procedures for fluo

ride dentifrice drug products. (a) A fluoride dentifrice drug product shall meet the biological test requirements for animal caries reduction and one of the following tests: Enamel solubility reduction or fluoride enamel uptake. The testing procedures for these biological tests are labeled Biological Testing Procedures for Fluoride Dentifrices; these testing procedures are on file under Docket No. 80N-0042 in the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and are available on request to that office.

(b) The United States Pharmacopeia fluoride dentifrice reference standards along with reference standard stability profiles (total fluoride, available fluoride ion, pH, and specific gravity) required to be used in the biological tests are available to any purchaser upon written request to the United States Pharmacopeial Convention, Inc., 1260

[60 FR 52507, Oct. 6, 1995; 60 FR 57927, Nov. 24, 1995; 61 FR 51187, Oct. 7, 1996)

8355.55 Principal display panel of all

fluoride rinse drug products. In addition to the statement of identity required in $355.50, the following statement shall be prominently placed on the principal display panel: “IMPORTANT: Read directions for proper use."

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Subpart c-Cholecystokinetic Drug

Products

357.201 Scope. 357.203 Definition. 357.210 Cholecystokinetic active ingredi

ents. 357.250 Labeling of cholecystokinetic drug

products. 357.280 Professional labeling,

Subparts D-H [Reserved]

8357.150 Labeling of anthelmintic

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 "pinworm treatment."

(b) Indication. The labeling of the product states, under the heading "Indication," the following: “For the treatment of pinworms." 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.

Subpart Deodorant Drug Products for

Internal Use

357.801 Scope. 357.803 Definitions. 357.810 Active ingredients for deodorant

drug products for internal use. 357.850 Labeling of deodorant drug products

for internal use,

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

(3) “This product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during, or after medication.”

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

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

(1) “Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness sometimes occur after taking this drug. If any of these conditions persist consult a doctor."

(2) “If you are pregnant or have liver disease, do not take this product unless directed by a doctor."

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

(1) Adults, children 12 years of age and over, and children 2 years to under 12 years of age: Oral dosage is a single dose of 5 milligrams of pyrantel base per pound, or 11 milligrams per kilogram, of body weight not to exceed 1 gram. Dosing information should be converted to easily understood directions for the consumer using the following dosage schedule:

(51 FR 27759, Aug. 1, 1986; 52 FR 7831, Mar. 13, 1987, as amended at 53 FR 35810, Sept. 15, 1988]

§ 357.152 Package inserts for anthel

mintic drug products. The labeling of the product contains a consumer package insert which includes the following information:

(a) A discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be visually identified before taking this medication.

(b) A detailed description of how to find and identify the pinworm.

(c) A commentary on the life cycle of the pinworm.

(d) A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading.

(e) The appropriate labeling information contained in 8 357.150

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(Collection of information requirement approved by the Office of Management and Budget under control number 0910-0232)

Depending on the product, the label should state the quantity of drug as a liquid measurement (e.g., teaspoonstul) or as the number of dosage units (e.g., tablets) to be taken for the varying body weights. (if appropriate, it is recommended that a measuring cup graduated by body weight and/or liquid measurement be provided with the product.) Manufacturers should present this information as appropriate for their product and may vary the format of this chart as necessary.

(51 FR 27759, Aug. 1, 1986, as amended at 52 FR 2515, Jan 23, 1987)

$ 357.180 Professional labeling.

The labeling provided to health professionals (but not to the general public) may contain an additional indication: “For the treatment of common roundworm infestation."

Subpart C-Cholecystokinetic

Drug Products

(2) “Read package insert carefully before taking this medication. Take only according to directions and do not exceed the recommended dosage unless directed by a doctor. Medication should only be taken on time as a single dose; do not repeat treatment unless directed by a doctor. When one individual in a household has pinworms, the entire household should be treated unless otherwise advised. See Warnings. If any worms other than pinworms are present before or after treatment, consult a doctor. If any symptoms or pinworms are still present after treatment, consult a doctor.

$ 357.201 Scope. (a) An

over-the-counter cholecystokinetic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart in addition to each of the general conditions established in 8330.1.

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

[48 FR 27005, June 10, 1983)

$ 357.203 Definition.

As used in this subpart:

Cholecystokinetic drug product. A drug product that causes contraction of the gallbladder and is used during the course of diagnostic gallbladder studies (cholecystography).

(48 FR 27005, June 10, 1983]

diagnostic gallbladder studies.” 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. [Reserved]

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

(1) "Take only when instructed by a doctor:'

(2) For products containing 50-percent aqueous emulsion of corn oil.

(1) "Shake well before using."

(ii) Oral dosage is 60 milliliters 20 minutes before diagnostic gallbladder X-ray or as directed by a doctor.

(3) For products containing hydrogeneated soybean oil. Oral dosage is 12.4 grams in a suitable, water-dispersible powder in 2 to 3 ounces of water. Stir briskly to prepare a suspension before using. Drink 20 minutes before diagnostic gallbladder x-ray or as directed by a doctor.

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

§ 357.210. Cholecystokinetic active in

gredients. The active ingredient of the product consists of any of the following when used within the specified concentration and dosage form established for each ingredient:

(a) 50-percent aqueous emulsion of corn oil.

(b) Hydrogenated soybean oil in a suitable, water-dispersible powder. The hydrogenated soybean oil is food-grade, partially hydrogenated with a melting point of 41 to 43.5 ° C, an iodine value of 65 to 69, and a fatty acid composition as follows:

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(48 FR 27005, June 10, 1983, as amended at 51 FR 16267, May 1, 1986; 52 FR 7830, Mar. 13, 1987; 54 FR 8321, Feb. 28, 1989)

8357.280 Professional labeling.

The labeling provided to health professionals (but not to the general public) may contain the following information for ingredients identified in $357.210: Indication. “For visualization of biliary ducts during cholecystography.”

(54 FR 8321, Feb. 28, 1989)

[54 FR 8321, Feb. 28, 1989)

Subparts D-H [Reserved)

8357.250 Labeling of cholecystokinetic

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 "gallbladder diagnostic agent.''

(b) Indications. The labeling of the product states, under the heading “Indications,” the following: “For the contraction of the gallbladder during

Subpart 1-Deodorant Drug Products for Internal Use

SOURCE: 55 FR 19865, May 11, 1990, unless otherwise noted.

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