THEIR DERIVATIVES, AND RELATED DRUG PREPARATIONS.

Warning-Not to be used by persons having glaucoma or excessive pressure within the eye, by elderly persons (where undiagnosed glaucoma or excessive pressure within the eye occurs most frequently), or by children under 6 years of age, unless directed by a physician. Discontinue use if blurring of vision, rapid pulse, or dizziness occurs. Do not exceed recommended dosage. Not for frequent or prolonged use. If dryness of the mouth occurs, decrease dosage. If eye pain occurs, discontinue use and see see your physician immediately as this may indicate undiagnosed glaucoma.

In the case of scopolamine or scopolamine aminoxide preparations indicated for insomnia, the portion of the above warning that reads "children under 6 years of age" should read instead "children under 12 years of age”. BORIC ACID (POWDERED, CRYSTALLINE, OR GRANULAR).

Warning-Do not use as a dusting powder, especially on infants, or take internally. Use only as a solution. Do not apply to badly broken or raw skin, or to large areas of the body. BROMIDES.

Caution-Use only as directed. Do not give to children or use in the presence of kidney disease. If skin rash appears or if nervous symptoms persist, recur frequently, or are unusual, discontinue use and consult physician.

CARBOLIC ACID (PHENOL) PREPARATIONS (MORE THAN 0.5 PERCENT) FOR EXTERNAL USE.

Warning-Use according to directions. Do not apply to large areas of the body. If applied to fingers or toes, do not bandage.

CATHARTICS AND LAXATIVES-IRRITANTS AND OTHER PERISTALTIC STIMULANTS.

Warning-Do not use when abdominal pain, nausea, or vomiting are present. Frequent or prolonged use of this preparation may result in dependence on laxatives.

Mercury preparations should have added to the "frequent use" statement, the words "and serious mercury poisoning".

Phenolphthalein preparations should bear, in addition to the general warning, the following statement:

Caution-If skin rash appears, do not use this or any other preparation containing phenolphthalein.

See also Mineral Oil Laxatives. CHLORATES: MOUTH WASH OR GAR

GLE.

Avoid swallowing.

COBALT PREPARATIONS (See also § 250.106 of this chapter.)

Warning-Do not exceed the recommended dosage. Do not administer to children under 12 years of age unless directed by physician. Do not use for more than 2 months unless directed by physician.

This warning is not required on articles containing not more than 0.5 milligram of cobalt as a cobalt salt per dosage unit and which recommend administration of not more than 0.5 milligram per dose and not more than 2 milligrams per 24-hour period. "COUGH-DUE-TO-COLD"

PREPARA

Caution-Do not apply to large areas of the body.

CREOSOTE, CRESOLS, GUAIACOL, AND SIMILAR SUBSTANCES IN DOUCHE PREPARATIONS.

Warning-The use of solutions stronger than those recommended may result in severe local irritation, burns, or serious poisoning. Mix as directed before pouring into douche bag. Do not use more often than twice weekly unless directed by physician.

DENTURE RELINERS, PADS, AND
CUSHIONS.
Warning-For

temporary use only. Long-term use of this product may lead to faster bone loss, continuing irritation, sores, and tumors. For Use Only Until a Dentist Can Be Seen. DENTURE REPAIR KITS.

Warning-For emergency repairs only. Long-term use of home-repaired dentures may cause faster bone loss, continuing irritation, sores, and tumors. This kit for emergency use only. See Dentist Without Delay.

DIARRHEA PREPARATIONS.

Warning-Do not use for more than 2 days or in the presence of high fever or in infants or children under 3 years of age unless directed by a physician. DOUCHE PREPARATIONS.

Warning-Do not use more often than twice weekly unless directed by physician.

See also Creosote * * * Douche for additional warning.

DRESSINGS, PROTECTIVE SPRAYON TYPE. (See also §310.201(a) (11) and (18) of this chapter.)

Warning-In case of deep or puncture wounds or serious burns consult physician. If redness, irritation, swelling or pain persists or increases or if infection occurs consult physician. Keep away from eyes or other mucous membranes. Avoid inhaling.

See also Dispensers Pressurized by Gaseous Propellants *** for additional warnings to be included for products under pressure.

IODINE AND IODIDES (ORAL).

If the article is an aspirin preparation, it should bear the first of the above two warning statements. In either case, the above information should appear on the label.

Caution-For children under 3 years of age, consult your physician; or

Caution-For younger children, consult your physician.

One of the two immediately preceding caution statements is required on the label of all aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered for administration to adults only.

If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement:

Caution-If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately.

Warning-Do not use otherwise than as directed. Keep out of the reach of children to avoid accidental poisoning.

If the preparation is a counterirritant or rubefacient the statement:

Caution-Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes.

If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement:

Caution-If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately.

SILVER.

Caution-Frequent or prolonged use of this preparation may result in permanent discoloration of skin and mucous membranes.

SODIUM PERBORATE MOUTHWASH AND GARGLE AND TOOTHPASTE.

Caution-Discontinue use if irritation or inflammation develops, or increases. Avoid swallowing.

SULFONAMIDE NOSE DROPS.

Caution-Do not use if a known allergy to sulfonamide drugs exists. SULFUR PREPARATION FOR EXTERNAL USE.

Caution-If undue skin irritation develops or increases, discontinue use and consult physician.

THROAT PREPARATIONS FOR TEMPORARY RELIEF OF MINOR SORE THROAT: LOZENGES, TROCHES, WASHES, GARGLES, ETC. (See also §201.315 of this chapter.)

Warning-Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician. TOOTHACHE PREPARATIONS.

For temporary use only until a dentist can be consulted.

ZINC STEARATE DUSTING POWDERS.

Warning-Keep out of the reach of infants and children; avoid inhaling.

[39 FR 11745, Mar. 29, 1974, as amended at 40 FR 8917, Mar. 3, 1975; 40 FR 13496, Mar. 27, 1975; 41 FR 10885, Mar. 15, 1976; 51 FR 27760, Aug. 1, 1986; 51 FR 35340, Oct. 2, 1986; 52 FR 15893, Apr. 30, 1987; 52 FR 30057, Aug. 12, 1987; 52 FR 47324, Dec. 11, 1987; 53 FR 7093, Mar. 4, 1988; 55 FR 31783, Aug. 3, 1990; 57 FR 58376, Dec. 9, 1992; 59 FR 43412, Aug. 23, 1994]

§ 369.21 Drugs; warning and caution statements required by regulations. ACETAMINOPHEN (N-ACETYL-pAMINOPHENOL) (See §310.201(a)(1) of this chapter.)

Warning-Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician.

If offered for use in arthritis, or rheumatism, in juxtaposition therewith, the statement:

Caution-If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately. ALCOHOL RUBBING COMPOUND. (See 26 CFR 182.855(a)(5); The National Formulary, Tenth Edition 1955, pp. 27– 28; and section 502(g) of the act).

Warning-For external use only. If taken internally serious gastric distrubances will result.

ANTIHISTAMINICS, ORAL (PHENYLTOLOXAMINE DIHYDROGEN CITRATE AND CHLOROTHEN CITRATE PREPARATIONS). (See §310.201(a)(4) and (a)(24) of this chapter.)

Caution-This preparation may cause drowsiness. Do not drive or operate machinery while taking this medication. Do not give to children under 6 years of age or exceed the recommended dosage unless directed by physician.

If offered for symptoms of colds, the statement:

Caution-If relief does not occur within 3 days, discontinue use and consult physician.

CARBETAPENTANE CITRATE PREPARATIONS. (See Cough-Due-to-Cold Preparations.)

"COUGH-DUE-TO-COLD” PREPARATIONS (CARBETAPENTANE CIT

RATE). (See §310.201(a)(20) of this chapter.)

Warning-Keep out of the reach of children. Do not administer to children under 2 years of age unless directed by physician. Persistent cough may indicate the presence of a serious condition. Persons with a high fever or persistent cough should not use this preparation unless directed by physician. DICYCLOMINE HYDROCHLORIDE WITH AN ANTACID. (See §310.201(a)(8) of this chapter.)

Warning-Do not exceed the recommended dosage. Do not administer to children under 12 years of age or use for a prolonged period unless directed by physician, since persistent or recurring symptoms may indicate a serious disease requiring medical attention. METHYLSULFATE USE.

DIPHEMANIL

FOR

EXTERNAL §310.201(a)(22) of this chapter.)

(See

Caution-If redness, irritation, swelling, or pain persists or increases, discontinue use and consult physician. DRUGS IN DISPENSERS PRESSURIZED BY GASEOUS PROPELLANTS. (See also §310.201(a) (11) and (18) of this chapter.)

The warnings herein shall appear prominently and conspicuously, but in no case may the letters be less than 16 inch in height.

If the label of any package is too small to accommodate the warnings, the Commissioner may establish by regulation an acceptable alternative method, e.g., a type size smaller than 1/16 inch in height. A petition requesting such a regulation, as an amendment to this paragraph, shall be submitted to the Dockets Management Branch in the form established in part 10 of this chapter.

Warning—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120° F. Keep out of reach of children.

In the case of products packaged in glass containers, the word "break" may be substituted for the word "puncture."

The words "Avoid spraying in eyes" may be deleted from the warning in the case of a product not expelled as a

In addition to the above warning, the label of a drug packaged in a self-pressurized container in which the propellant consists in whole or in part of a halocarbon or hydrocarbon shall bear the following warning:

Warning-Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

The warning is not required for the following products:

(a) Products expelled in the form of a foam or cream, which contain less than ten percent propellant in the container;

(b) Products in a container with a physical barrier that prevents escape of the propellant at the time of use;

(c) Products of a net quantity of contents of less than 2 ozs. that are designed to release a measured amount of product with each valve actuation;

(d) Products of a net quantity of contents of less than 1⁄2 oz.

DYCLONINE HYDROCHLORIDE. (See §310.201(a)(23) of this chapter.)

Caution-Do not use in the eyes. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by physician. Do not use, but consult physician for deep or puncture wounds or serious burns. Do not use in case of rectal bleeding, as this may indicate serious disease.

HEXADENOL. (See §310.201(a)(11) of this chapter.)

Caution-Do not use for treatment of serious burns or skin conditions or for conditions which persist for prolonged periods. In such cases, consult your physician. Do not spray in vicinity of eyes, mouth, nose, or ears. Do not store above 120° F.

INSULIN. (See §429.11(c) of this chapter.)

Insulin (40 or 100 U.S.P. units per milliliter):

Caution-Do not remove stopper. Not for intravenous nor intramuscular use. Do not use after expiration date shown on outside wrapper or container. Do not use if drug has become viscous or if

In addition to the above warnings, the following statements should be included in the labeling: "Keep in a cold place, avoid freezing. Failure to follow directions for use may lead to infection." Potamine zinc insulin, isophane insulin, lente insulin, semilente insulin, or ultralente insulin:

Caution-Do not remove stopper. Not for intravenous nor intramuscular use. Do not use after expiration date shown on outside wrapper or container. Do not substitute for any other insulincontaining drug unless directed by physician. Do not use when precipitate has become lumped or granular in appearance or has formed a deposit of solid particles on the wall of the container.

In addition to the above warnings for protamine zinc insulin ***, the following statements should be included in the labeling of these preparations: "Keep in a cold place, avoid freezing"; "Shake carefully" or "Shake well before using" or "Shake well" or "Shake carefully to suspend all particles"; "Failure to follow directions for use may lead to infection”. Globin zinc insulin:

Caution-Do not remove stopper. Not for intravenous nor intramuscular use. Do not use after expiration date shown on outside wrapper or container. Do not use if any turbidity or precipitate has developed in the solution. Do not substitute for any other insulin-containing drug unless directed by physician.

In addition to the above warnings for globin zinc insulin, the following statements should be included in the labeling: "Keep in a cold place, avoid freezing. Failure to follow directions for use may lead to infection”.

IPECAC SYRUP IN ONE-FLUID OUNCE CONTAINERS FOR EMERGENCY TREATMENT OF POISONING, TO INDUCE VOMITING. (See §201.308 of this chapter.)

Ipecac syrup packaged for over-thecounter sale must bear statements to the following effect, in a prominent and conspicuous manner:

The following statement (boxed and in red letters):

"For emergency use to cause vomiting in poisoning. Before using, call