PART 369—INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 39 FR 11745, Mar. 29, 1974, unless otherwise noted. Editorial Note: Nomenclature changes to part 369 appear at 69 FR 13717, Mar. 24, 2004. Subpart A—Definitions and Interpretations § 369.1 Purpose of issuance. The warning and caution statements suggested in subparts B and C of this part, for inclusion in the label or labeling of drugs and devices subject to section 502(d) and (f)(2) and other relevant provisions of the Federal Food, Drug, and Cosmetic Act are issued for the purpose of assisting industry in preparing proper labeling for these articles for over-the-counter sale and in meeting the legal requirements of the act that the label or labeling of drugs and devices bear adequate warnings, in such manner and form as are necessary for the protection of users. Only section 502(d) of the act requires use of the specific language included in these suggested warning and caution statements. These suggested warning or caution statements are illustrative of those that may be necessary or desirable. It is the responsibility of the manufacturer, packer, shipper, or distributor in interstate commerce to see that such statements are adequate for compliance with the provisions of the law. Omission of any article from this suggested list does not relieve drugs and devices subject to provisions of the act from bearing adequate warning or caution statements where such statements are necessary or desirable for the protection of the user. § 369.2 Definitions. (a) As used in this part, the term act (b) The terms drugs devices (c) Official compendia are defined in section 201(j) of the act. § 369.3 Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C). Drugs exempted from prescription-dispensing requirements under section 503(b)(1)(C) of the act are subject to the labeling requirements prescribed in § 310.201(a) of this chapter. Although, for convenience, warning and caution statements for a number of the drugs named in § 310.201 of this chapter (cross-referenced in the text of this part) are included in subpart B of this part, the inclusion of such drugs in §§ 369.20 or 369.21 in no way affects the requirements for compliance with § 310.201(a) of this chapter, or the provisions of an effective application pursuant to section 505(b) of the act. [85 FR 72907, Nov. 16, 2020] § 369.4 Warnings suggested for drugs by formal or informal statements of policy. The warning and caution statements included in subpart B of this part in no way affect any warning statement suggested for such drugs or devices by any statement of policy or interpretation in subchapter C of this chapter. [39 FR 11745, Mar. 29, 1974, as amended at 40 FR 13496, Mar. 27, 1975] § 369.6 [Reserved] § 369.7 Warnings required by official compendia. Any drug included in the official compendia defined by the act shall bear such warning or caution statement as may be required by such compendia, and no statement in subpart B or subpart C of this part is intended to alter, modify, or permit the omission of any such statement required by such compendia. § 369.8 Warning statements in relation to conditions for use. The mention in any warning or caution statement included in subparts A, B, and C of this part, of a disease condition does not imply a finding on the part of the Food and Drug Administration that any drug or device is efficacious in such condition; nor is any drug or device bearing labeling referring to such disease condition precluded from regulatory action under the applicable provisions of the act if such claim is considered to be misbranding. § 369.9 General warnings re accidental ingestion by children. Section 369.20 includes under certain items, but not all medicines, the statement: “Keep this and all medicines out of children's reach. In case of overdose, get medical help or contact a Poison Control Center right away,” or “Keep out of reach of children.” However, in view of the possibility of accidental ingestion of drugs, it is not only suggested but is recommended that one of these statements be used on the label of all drug products. [64 FR 13296, Mar. 17, 1999] § 369.10 Conspicuousness of warning statements. Necessary warning statements should appear in the labeling prominently and conspicuously as compared to other words, statements, designs, and devices, and in bold type on clearly contrasting background, in order to comply with the provisions of section 502(c) and (f)(2) of the act. The warning statements should be placed in the labeling in juxtaposition with the directions for use and, in any case, should appear on the label when there is sufficient label space in addition to mandatory label information. Subpart B—Warning and Caution Statements for Drugs § 369.20 Drugs; recommended warning and caution statements. ACETANILID. Warning ACETOPHENETIDIN CONTAINING PREPARATIONS. (See § 201.309 of this chapter.) Warning ANESTHETICS FOR EXTERNAL USE (LOCAL ANESTHETICS). (See also § 310.201(a)(19) and (23) of this chapter.) Caution ANTIHISTAMINICS FOR EXTERNAL USE (EXCEPT PREPARATIONS FOR OPHTHALMIC USE). Caution ANTIHISTAMINICS, ORAL. (See also § 310.201(a)(4) and (a)(24) of this chapter.) Caution The reference to drowsiness is not required on preparations for the promotion of sleep or on preparations that are shown not to produce drowsiness. ANTIPYRINE. Warning ANTISEPTICS FOR EXTERNAL USE. Caution The reference to wounds and burns is not required on preparations intended solely for diaper rash. ARSENIC PREPARATIONS. Warning BELLADONNA PREPARATIONS AND PREPARATIONS OF ITS ALKALOIDS (ATROPINE, HYOSCYAMINE, AND SCOPOLAMINE (HYOSCINE); HYOSCYAMUS, STRAMONIUM, THEIR DERIVATIVES, AND RELATED DRUG PREPARATIONS. Warning 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 BROMIDES. Caution CARBOLIC ACID (PHENOL) PREPARATIONS (MORE THAN 0.5 PERCENT) FOR EXTERNAL USE. Warning CATHARTICS AND LAXATIVES—IRRITANTS AND OTHER PERISTALTIC STIMULANTS. Warning 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 See also Mineral Oil Laxatives. CHLORATES: MOUTH WASH OR GARGLE. Avoid swallowing. COBALT PREPARATIONS (See also § 250.106 of this chapter.) Warning 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” PREPARATIONS. (See also § 310.201(a)(20) of this chapter.) Warning COUNTERIRRITANTS AND RUBEFACIENTS. Caution If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement: Caution See also “Salicylates” in this section for additional warnings for preparations containing methyl salicylate. CREOSOTE, CRESOLS, GUAIACOL, AND SIMILAR SUBSTANCES IN PREPARATIONS FOR EXTERNAL USE. Caution CREOSOTE, CRESOLS, GUAIACOL, AND SIMILAR SUBSTANCES IN DOUCHE PREPARATIONS. Warning DENTURE RELINERS, PADS, AND CUSHIONS. Warning—For temporary use only. DENTURE REPAIR KITS. Warning—For emergency repairs only. DOUCHE PREPARATIONS. Warning See also Creosote * * * Douche for additional warning. DRESSINGS, PROTECTIVE SPRAY-ON TYPE. (See also § 310.201(a) (11) and (18) of this chapter.) Warning See also Dispensers Pressurized by Gaseous Propellants * * * for additional warnings to be included for products under pressure. IODINE AND IODIDES (ORAL). Caution MERCURY PREPARATIONS FOR EXTERNAL USE. Warning MINERAL OIL LAXATIVES. (See also § 201.302 of this chapter.) Caution NASAL PREPARATIONS: VASOCONSTRICTORS (PHENYL- PROPANOLAMINE). Caution NUX VOMICA AND STRYCHNINE PREPARATIONS. “Do not use more than the recommended dosage. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.” OPHTHALMIC PREPARATIONS. (See also § 200.50 of this chapter.) Boric acid offered for use in the preparation of ophthalmic solutions should bear the statement: Prepare solution by boiling in water. Store in a sterile container. Prepare sufficient for one day's use and discard unused portion. PHENACETIN-CONTAINING PREPARATION. (See acetophenetidin.) PHENYLPROPANOLAMINE HY- DROCHLORIDE PREPARATIONS, ORAL. Caution POTASSIUM PERMANGANATE AQUEOUS SOLUTIONS (CONTAINING NOT MORE THAN 0.04 PERCENT POTASSIUM PERMANGANATE). (See § 250.108 of this chapter.) Warning QUININE AND OTHER CINCHONA DERIVATIVES (EXCEPT FOR USE IN MALARIA). Caution RESINS, OLEORESINS, AND VOLATILE OILS. Caution RESORCINOL (NOT THE MONOACETATE) HAIR PREPARATIONS. Caution SALICYLATES, INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND PREPARATIONS OF AMINOSALICYLIC ACID AND ITS SALTS). (See also § 201.314 of this chapter.) “Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away;” or “Keep out of reach of children.” 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 Caution 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 SALICYLATES: METHYL SALICYLATE (WINTERGREEN OIL). (See also §§ 201.303 and 201.314 of this chapter.) “Do not use otherwise than as directed. Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.” If the preparation is a counter-irritant or rubefacient the statement: Caution If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement: Caution SILVER. Caution SODIUM PERBORATE MOUTHWASH AND GARGLE AND TOOTHPASTE. Caution SULFONAMIDE NOSE DROPS. Caution SULFUR PREPARATION FOR EXTERNAL USE. Caution THROAT PREPARATIONS FOR TEMPORARY RELIEF OF MINOR SORE THROAT: LOZENGES, TROCHES, WASHES, GARGLES, ETC. (See also § 201.315 of this chapter.) Warning TOOTHACHE PREPARATIONS. For temporary use only until a dentist can be consulted. ZINC STEARATE DUSTING POWDERS. “Keep out of reach of children; avoid inhaling. If swallowed, get medical help or contact a Poison Control Center right away.” [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; 64 FR 13296, Mar. 17, 1999; 68 FR 18882, Apr. 17, 2003; 68 FR 34293, June 9, 2003] § 369.21 Drugs; warning and caution statements required by regulations. ACETAMINOPHEN (N-ACETYL- p Warning If offered for use in arthritis, or rheumatism, in juxtaposition therewith, the statement: Caution 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 ANTIHISTAMINICS, ORAL (PHENYLTOLOXAMINE DIHYDROGEN CITRATE AND CHLOROTHEN CITRATE PREPARATIONS). (See § 310.201(a)(4) and (a)(24) of this chapter.) Caution If offered for symptoms of colds, the statement: Caution DICYCLOMINE HYDROCHLORIDE WITH AN ANTACID. (See § 310.201(a)(8) of this chapter.) Warning DIPHEMANIL METHYLSULFATE FOR EXTERNAL USE. (See § 310.201(a)(22) of this chapter.) Caution 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 1/16 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 Warning 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 spray, or that is intended to be used in the eyes. 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 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 DYCLONINE HYDROCHLORIDE. (See § 310.201(a)(23) of this chapter.) Caution HEXADENOL. (See § 310.201(a)(11) of this chapter.) Caution 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-the-counter 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 physician, the Poison Control Center, or hospital emergency room immediately for advice.” The following warning: Warning—Keep out of reach of children. Do not use in unconscious persons. Ordinarily, this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates such as kerosene, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested. ISOAMYLHYRDOCUPREINE AND ZOLAMINE HYDROCHLORIDE RECTAL PREPARATIONS FOR EXTERNAL USE (See § 310.201(a)(3) of this chapter.) Warning— NEOMYCIN SULFATE WITH A VASOCONSTRICTOR, IN NASAL PREPARATIONS (SPRAY OR DROPS). Caution— PRAMOXINE HYDROCHLORIDE FOR EXTERNAL USE. (See § 310.201(a)(19) of this chapter.) Caution— SODIUM GENTISATE. (See §§ 201.314 and 310.301(a)(2) of this chapter.) Warning “Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.” If offered for use in arthritis or rheumatism, in juxtaposition therewith, the statement: Caution TUAMINOHEPTANE SULFATE NASAL PREPARATIONS. (See § 310.201(a)(16) of this chapter.) Caution— VIBESATE PREPARATIONS. (See § 310.201(a)(18) of this chapter.) Caution— Warning— [39 FR 11745, Mar. 29, 1974] Editorial Note: For Federal Register www.govinfo.gov.