• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of Nov 29, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[CITE: 21CFR349]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE
 
PART 349OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
 

Subpart B - Active Ingredients

Sec. 349.10 Ophthalmic astringent.

The active ingredient and its concentration in the product is as follows: Zinc sulfate, 0.25 percent.

Sec. 349.12 Ophthalmic demulcents.

The active ingredients of the product consist of any of the following, within the established concentrations for each ingredient:

(a) Cellulose derivatives:

(1) Carboxymethylcellulose sodium, 0.2 to 2.5 percent.

(2) Hydroxyethyl cellulose, 0.2 to 2.5 percent.

(3) Hypromellose, 0.2 to 2.5 percent.

(4) Methylcellulose, 0.2 to 2.5 percent.

(b) Dextran 70, 0.1 percent when used with another polymeric demulcent agent in this section.

(c) Gelatin, 0.01 percent.

(d) Polyols, liquid:

(1) Glycerin, 0.2 to 1 percent.

(2) Polyethylene glycol 300, 0.2 to 1 percent.

(3) Polyethylene glycol 400, 0.2 to 1 percent.

(4) Polysorbate 80, 0.2 to 1 percent.

(5) Propylene glycol, 0.2 to 1 percent.

(e) Polyvinyl alcohol, 0.1 to 4 percent.

(f) Povidone, 0.1 to 2 percent.

[53 FR 7090, Mar. 4, 1988, as amended at 68 FR 32982, June 3, 2003]

Sec. 349.14 Ophthalmic emollients.

The active ingredients of the product consist of any of the following:

(a) Lanolin preparations:

(1) Anhydrous lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the monograph.

(2) Lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the monograph.

(b) Oleaginous ingredients:

(1) Light mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph.

(2) Mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph.

(3) Paraffin, up to 5 percent in combination with one or more other emollient agents included in the monograph.

(4) Petrolatum, up to 100 percent.

(5) White ointment, up to 100 percent.

(6) White petrolatum, up to 100 percent.

(7) White wax, up to 5 percent in combination with one or more other emollient agents included in the monograph.

(8) Yellow wax, up to 5 percent in combination with one or more other emollient agents included in the monograph.

Sec. 349.16 Ophthalmic hypertonicity agent.

The active ingredient and its concentration in the product is as follows: Sodium chloride, 2 to 5 percent.

Sec. 349.18 Ophthalmic vasoconstrictors.

The active ingredient of the product consists of one of the following, within the established concentration for each ingredient:

(a) Ephedrine hydrochloride, 0.123 percent.

(b) Naphazoline hydrochloride, 0.01 to 0.03 percent.

(c) Phenylephrine hydrochloride, 0.08 to 0.2 percent.

(d) Tetrahydrozoline hydrochloride, 0.01 to 0.05 percent.

Sec. 349.20 Eyewashes.

The active ingredient of the product is purified water. The product also contains suitable tonicity agents to establish isotonicity with tears, suitable agents for establishing pH and buffering to achieve the same pH as tears, and a suitable preservative agent.

[68 FR 7921, Feb. 19, 2003]

Sec. 349.30 Permitted combinations of active ingredients.

The following combinations are permitted provided each active ingredient is present within the established concentration, and the product is labeled in accordance with § 349.79.

(a) Any single ophthalmic astringent active ingredient identified in § 349.10 may be combined with any single ophthalmic vasoconstrictor active ingredient identified in § 349.18.

(b) Any two or three ophthalmic demulcent active ingredients identified in § 349.12 may be combined.

(c) Any single ophthalmic demulcent active ingredient identified in § 349.12 or any ophthalmic demulcent combination identified in paragraph (b) of this section may be combined with any single ophthalmic vasoconstrictor identified in § 349.18.

(d) Any single ophthalmic astringent active ingredient identified in § 349.10 may be combined with any single ophthalmic vasoconstrictor active ingredient identified in § 349.18 and any single ophthalmic demulcent identified in § 349.12 or ophthalmic demulcent combination identified in paragraph (b) of this section.

(e) Any two or more emollient active ingredients identified in § 349.14 may be combined as necessary to give the product proper consistency for application to the eye.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 53 FR 7090, Mar. 4, 1988, unless otherwise noted.

-
-