ingredient(s) or component(s) in the food. The following requirements shall apply unless modified by a specific regulation in this part.

(1) The presence or absence of a characterizing ingredient or component shall be declared by the words "containing (or contains) "containing (or contains) no

or

or "no or "does not contain -," with the blank being filled in with the common or usual name of the ingredient or component.

(2) The need for the user of a food to add any characterizing ingredient(s) or component(s) shall be declared by an appropriate informative statement.

(3) The statement(s) required under paragraph (c) (1) and/or (2) of this section shall appear following or directly below the part of the common or usual name of the food required by paragraphs (a) and (b) of this section, in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the alternatives established under paragraph (b)(2) (i) and (ii) of this section.

(d) A common or usual name of a food may be established by common usage or by establishment of a regulation in this part, in a standard of identity, or in other regulations in this chapter.

(Secs. 201(n), 403, 701(a), 52 Stat. 1041 as amended, 1047-48 as amended, 1055 (21 U.S.C. 321(n), 343, 371(a)))

[41 FR 38627, Sept. 10, 1976. Redesignated at 42 FR 14091, Mar. 15, 1977]

(a) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to issue, amend, or revoke, under this part, a regulation prescribing a common or usual name for a food, pursuant to Part 10 of this chapter.

(b) If the principal display panel of a food for which a common or usual name regulation is established is too small to accommodate all mandatory requirements, the Commissioner may establish by regulation an acceptable alternative, e.g., a smaller type size. A petition requesting such a regulation,

which would amend the applicable regulation, shall be submitted pursuant to Part 10 of this chapter.

(Secs. 201(n), 403, 701(a), 52 Stat. 1041 as amended, 1047-48 as amended, 1055 (21 U.S.C. 321(n), 343, 371(a)))

[42 FR 4716, Jan. 25, 1977; 42 FR 10980, Feb. 25, 1977. Redesignated at 42 FR 14091, Mar. 15, 1977, and amended at 42 FR 15675, Mar. 22, 1977; 42 FR 24254, May 13, 1977]

505-INTERPRETIVE

PART STATEMENTS RE: WARNINGS ON ANIMAL DRUGS FOR OVER-THECOUNTER SALE

Subpart A-Definitions and Interpretations

Sec.

505.3 Warnings on animal drugs intended for administration to diseased animals.

Subpart B-Required Warning and Caution Statements

505.10 Animal drug warning and caution statements required by regulations.

Subpart C-Voluntary Warning and Caution Statements

505.20 Recommended animal drug warning and caution statements.

AUTHORITY: Secs. 502, 503, 506, 507, 701, 52 Stat. 1050, as amended, 1052, as amended, 1055-1056, as amended, 52 Stat. 854; 55 Stat. 851; 59 Stat. 463, as amended (21 U.S.C. 352, 353, 356, 357, 371).

SOURCE: 40 FR 13805, Mar. 27, 1975, unless otherwise noted.

Subpart A-Definitions and
Interpretations

§ 505.3 Warnings on animal drugs intended for administration to diseased animals.

None of the warning or caution statements recommended for use in the labeling of drugs intended for administration to diseased animals shall be construed to suggest or imply that any product of a diseased animal is suitable for food use. (See section 402(a)(5) of the act.)

Subpart B-Required Warning and Caution Statements

§ 505.10 Animal drug warning and caution statements required by regulations. ANIMAL FEED CONTAINING PENICILLIN, STREPTOMYCIN, DIHYDROSTREPTOMYCIN, CHLORTETRACYCLINE, TETRACYCLINE, CHLORAMPHENICOL, OR BACITRACIN, WITH OTHER DRUGS. (See § 510.515 of this chapter.)

A warning to the following effect is required when animal feeds containing any of the above-named antibiotics also contain the following drugs: Arsanilic acid, sodium arsanilate, or 3nitro-4-hydroxyphenol arsonic acid (3nitro-4-hydroxyphenylarsonic acid) for poultry and swine. (See § 510.515 (a) and (b) of this chapter.)

Warning-Discontinue use 5 days before the treated animals are slaughtered for human consumption.

Chlortetracycline for leptospirosis of swine. (See § 510.515(b)(41) of this chapter.)

A warning to the following effect is required on preparations containing, per ton of feed, 400 grams of chlortetracycline:

Warning-Discontinue use 10 days before the treated animals are slaughtered for human consumption. Hygromycin B for swine. (See § 510.515(b) of this chapter.)

Warning-Discontinue use 48 hours before the treated swine are slaughtered for human consumption.

Nystatin for turkeys. (See § 510.515(b) of this chapter.)

Warning-If used in laying hens, eggs are to be used for hatching purposes only.

ANTIBIOTIC-CONTAINING PREPFOR VETERINARY

ARATIONS

USE. (See Parts 540, 544, 546, 548 and 555 of this chapter.)

All drugs containing penicillin, streptomycin, dihydrostreptomycin, chlortetracycline, tetracycline, chloramphenicol, or bacitracin or any of their derivatives, labeled solely for veterinary use and bearing directions for use by the laity, are required to bear a label statement to the effect "For veterinary use only."

BACITRACIN-CONTAINING OINTMENTS. (See Part 548 of this chapter.)

All bacitracin-containing ointments are required to bear the label statements:

For use only in the prevention of infection in minor cuts and abrasions. Use of the drug should be discontinued and a veterinarian consulted if signs of infection or irritation appear. BACITRACIN- (OR ZINC BACITRACIN-) POLYMYXIN OINTMENT; BACITRACIN - POLYMYXIN - NEOMYCIN OINTMENT. (See §§ 448.510c(a) and 448.510e(a) of this chapter.)

These drugs are required to bear a label statement to the effect "For use only in the prevention of infection in minor cuts and abrasions. Use of the drug should be discontinued and a veterinarian consulted if signs of infection or irritation appear."

If they are in liquid form they also bear the statement: "Not for injection."

BACITRACIN OR FEED GRADE BACITRACIN POWDER ORAL VETERINARY; BACITRACIN METHYLENE DISALICYLATE AND STREPTOMYCIN SULFATE CAPSULES, POWDER, OR TABLETS ORAL VETERINARY. (See §§ 548.112d(a), 548.112b(a) of this chapter.)

These drugs are required to bear the label statement: "For oral veterinary use only."

CHLORAMPHENICOL

OPHTHAL

CILLIN. (See § 440.81(a) of this chapter.)

If represented for use as a treatment for mastitis, the statement: "Important-Milk from treated segments of udders should be discarded or used for purposes other than human consumption for at least 72 hours after the last treatment."

BUFFERED PENICILLIN POWDER, PENICILLIN POWDER WITH BUFFERED AQUEOUS DILUENT; DIBENZYLAMINE PENICILLIN AND POTASSIUM PENICILLIN POWDER, BUFFERED; PENICILLIN WITH VASOCONSTRICTOR. (See §§ 540.174a(a) and 540.160(a) of this chapter.)

Warning-Not for injection. CRYSTALLINE

PENICILLINSTREPTOMYCIN-(OR DIHYDROSTREPTOMYCIN-) POLYMYXINOXYTETRACYCLINE

CARBOMYCIN POWDER VETERINARY. (See § 540.881(a) of this chapter.)

These drugs are required to bear the label statement: "For udder instillations of cattle only."

EPHEDRINE PENICILLIN TABLETS. (See § 540.163(a) of this chapter.)

Warning-Not for injection or oral

use.

EPINEPHRINE INJECTION 1:1000 in 10-MILLILITER CONTAINERS FOR EMERGENCY TREATMENT OF ANAPHYLACTOID SHOCK IN CATTLE, HORSES, SHEEP, AND SWINE. (See § 500.65 of this chapter.) The label for epinephrine injection 1:1000 packaged for over-the-counter sale for veterinary use must bear the following statements in a prominent and conspicuous manner: "For emergency use only in the treatment of anaphylactoid shock.

"Usual dosage: Cattle, horses, sheep, and swine-1 cubic centimeter per 100 pounds of body weight. Inject subcutaneously."

The labeling must also bear a description of the symptoms of anaphylactoid shock including glassy eyes, increased salivation, grinding of the teeth, rapid breathing, muscular tremors, staggering gait, and collapse with death following. These symptoms may appear shortly after injection of a bacterin, vaccine, or antibiotic.

PREP

PENICILLIN-CONTAINING ARATIONS FOR INTRAMUSCULAR USE ONLY. (See §§ 540.250(a), 540.253, 540.255c(a), 540.265a, 540.265b(a), 540.274a(a), 540.274f(a), 540.281a(a) of this chapter.)

All these preparations are required to bear the label statement: "For intramuscular use only."

PENICILLIN-CONTAINING OINTMENTS. (See Part 540 of this chapter.)

If these preparations are labeled solely for udder instillations of cattle and are packaged in glass containers, they are required to bear the label statements: "Not for injection. For udder instillations of cattle only." PENICILLIN FOR SURFACE APPLICATION.

If the drug is not sterile, the statements: "Not sterile-Not for injection-Not to be used in deep wounds or body cavities."

PROCAINE PENICILLIN AND STREPTOMYCIN (OR DIHYDROSTREPTOMYCIN) IN OIL; DIBENZYLAMINE PENICILLIN AND

STREPTOMYCIN (OR DIHYDROSTREPTOMYCIN) IN OIL; PROCAINE PENICILLIN-STREPTOMYCIN- (OR DIHYDROSTREPTOMYCIN-) POLYMYXIN IN OIL (OR OINTMENT). (See §§ 540.274e(a) and 540.260(a) of this chapter.)

These drugs are required to bear the label statements: "For udder instillations of cattle only" or "For subcutaneous injection in fowl only. Inject in the neck immediately behind the head."

PROCAINE PENICILLIN IN OIL; PROCAINE PENICILLIN AND STREPTOMYCIN (OR DIHYDROSTREPTOMYCIN) IN OIL; PENICILLIN-STREPTOMYCIN-(OR DIHYDROSTREPTOMYCIN-) NEOMYCIN IN OIL; BENZATHINE PENICILLIN G IN OIL; BENZATHINE PENICILLIN G-PROCAINE PENICILLIN GSTREPTOMYCIN (OR DIHYDROSTREPTOMYCIN) IN OIL. (See §§ 540.255b, 540.274c(a),

540.274e(a) of this chapter.)

and

These drugs are required to bear the label statements:

"For udder instillations of cattle only" (if intended for such use): or

"For subcutaneous injection in fowl only. Inject in the neck immediately behind the head." (if packaged and labeled solely for subcutaneous injection in fowl).

STREPTOMYCIN FOR TOPICAL USE. (See § 544.370a of this chapter.) Caution-Not for intravenous or systemic medication.

DISPENSERS PRESSURIZED BY GASEOUS PROPELLANTS FOR DRUGS

The label on each package of a drug in a self-pressurized container in which the propellant consists in whole or in part of a fully halogenated chlorofluoroalkane (chlorofluorocarbon) shall bear the following warning:

Warning-Contains a chlorofluorocarbon that may harm the public health and environment by reducing ozone in the upper atmosphere.

This required warning for self-pressurized containers that contain a fully halogenated chlorofluorocarbon shall appear on an appropriate panel with such prominence and conspicuousness

as to render it likely to be read and understood by ordinary individuals under normal conditions of purchase. The warning may appear on a firmly affixed tag, tape, card, or sticker or similar overlabeling attached to the package. The warning shall appear prominently and conspicuously as compared to other words, statements, designs, or devices and in bold type on contrasting background, but in no case may the letters be less than 16 inch in height.

The warning is required only on a self-pressurized container that uses a chlorofluorocarbon in whole or in part as a propellant to expel from the container liquid or solid material different from the propellant.

(Secs. 291(n), 301, 402, 403, 501, 502, 505, 507, 512, 601, 602, 701(a), 52 Stat. 1041-1043 as amended, 1046-1048 as amended, 1049, 1051-1053 as amended, 1054-1055, 57 Stat. 463 as amended, 82 Stat. 343-351 (21 U.S.C. 321(n), 331, 342, 343, 351, 352, 355, 357, 360b, 361, 362, and 371(a)); sec. 102(2), 83 Stat. 853 (42 U.S.C. 4332); 21 CFR 5.1)

[40 FR 13805, Mar. 27, 1975, as amended at 41 FR 10886, 11011, Mar. 15, 1976; 41 FR 38768, Sept. 13, 1976; 42 FR 22033, Apr. 29, 1977; 44 FR 22053, Apr. 13, 1979; 47 FR 51563, Nov. 16, 1982]

Caution-In case of deep or puncture wounds or serious burns consult veterinarian. If redness, irritation, or swelling persists or increases, discontinue use and consult veterinarian. CARBOLIC ACID (PHENOL) PREPARATIONS (MORE THAN 0.5 PERCENT) FOR EXTERNAL USE.

Caution-Use only as directed. Avoid contact with the eyes and mucous membranes. Do not apply to large areas of broken skin. Do not use on cats.

CORTISONE, HYDROCORTISONE, PREDNISOLONE AND PREDNISONE PREPARATIONS FOR EXTERNAL USE.

Caution-Do not use where infection (pus) is present, since the drug may allow infection to spread. If redness, irritation, or swelling persists or increases, discontinue use and consult veterinarian.

COUNTERIRRITANTS AND RUBE

FACIENTS.

Caution-Do not apply to irritated skin or if excessive irritation develops. Avoid getting into eyes or on mucous membranes.

CREOSOTE, CRESOLS, GUAIACOL,

AND SIMILAR SUBSTANCES IN PREPARATIONS FOR EXTERNAL

USE.

Caution--Use only as directed. Avoid contact with the eyes and mucous membranes. Do not apply to large areas of broken skin. Not recommended for use on cats.

DIARRHEA PREPARATIONS.

Caution-If symptoms persist after using this preparation for 2 or 3 days, consult veterinarian.

DISPENSERS PRESSURIZED
GASEOUS

BY

PROPELLANT FOR

DRUGS FOR EXTERNAL USE. Caution-Keep away from eyes or other mucous membranes. Avoid inhaling.

This warning is not necessary for preparations especially designed for use on mucous membranes.

Warning-Contents under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 130° Farenheit may cause bursting. Never throw container into fire or incinerator. DRESSINGS, PROTECTIVE SPRAYON TYPE.

Caution-In case of deep or puncture wounds or serious burns or if redness, irritation, or swelling persists or increases, consult veterinarian.

Keep away form eyes or other mucous membranes. Avoid inhaling.

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

ESTROGEN PELLETS IN CATTLE AND SHEEP.

(name of the anatomical area) only. Any other location may result in violation of Federal law. Do not attempt saivage of implanted site for human or animal food.

NICARBAZIN FOR POULTRY.

Warning-Do not feed to laying hens in production. Discontinue use at least 4 days before slaughtering birds for food to eliminate the drug from the food.

OPHTHALMIC PREPARATIONS.

Caution-If condition persists or increases discontinue use and consult veterinarian. Keep container tightly closed.

Solutions should also include the following statement: "Do not touch applicator tip to any surface, since this may contaminate solution."