Exact-Rx Sodium Sulfacetamide Wash 10%

EXACT-RX SODIUM SULFACETAMIDE WASH 10%- sulfacetamide sodium liquid
Exact-Rx, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

INDICATIONS: Sodium Sulfacetemide 10% Wash is intended

for topical application in the following scaling dermatoses:

seborrheic dermatisis and seborrhea sicca (dandruff). It also is

indicated for the treatment of secondary bacterial infections of

the skin due to organisms susceptible to sulfonamides.

DIRECTIONS FOR USE: Wash affected areas twice daily

(morning and evening) or as directed by your physician. Rinse

thoroughly and pat dry. See package insert for complete product information.

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR

OPHTHALMIC USE. (KEEP AWAY FROM EYES).

KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

In case of accidental ingestion contact a poison

control center immediately. Keep container tightly closed.

CONTRAINDICATIONS: Sodium Sulfacetamide 10% Wash is

contraindicated in persons with know or suspected hypersensitivity to sulfonamides.

Each gram contains 100 mg of sodium sulfacetamide USP in a

vehicle consisting of: citric acid, cocamidopropyl betaine, disodium EDTA,

glyceryl stearate, methylparaben, PEG-6 caprylic/capric

glycerides, PEG-60 almond glycerides, PEG-150 pentaerythrityl

tetrastearate, polysorbate 60, purified water, sodium lauryl

sulfate, sodium thiosulfate and xanthan gum.

Store at 25C (77F); excursions permitted to 15 to 30C (59 to

86F). See USP Controlled Room. Protect from freezing.

See bottle for lot number and expiration date

Manufactured in the U.S.A. for

Exact-Rx, Inc., Melville, NY 11747

SODIUM SULFACETAMIDE 10% WASH

(sodium sulfacetamide 10%)

Rx Only

FOR EXTERNAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Description: Each gram contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: ammonium lauryl sulfate, butylated hydroxytoluene, ceteareth-25, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, guar gum, methylparaben, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.

HOW SUPPLIED: Sodium Sulfacetamide Wash 10% is available in a 6 fl oz (170 mL) bottle, NDC 42808-101-06, and in a 12 fl oz
(354.8 mL) bottle, NDC 42808-101-12.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-101-205-00
Iss:12/16

EXACT-RX SODIUM SULFACETAMIDE WASH 10% sodium sulfacetamide liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42808-103 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength AMMONIUM LAURYL SULFATE BUTYLATED HYDROXYTOLUENE COCAMIDOPROPYL BETAINE CETEARETH-25 CETYL ALCOHOL EDETATE DISODIUM ANHYDROUS GLYCERIN GUAR GUM METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM THIOSULFATE STEARYL ALCOHOL TRIACETIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42808-103-06 177 mL in 1 BOTTLE None 2 NDC:42808-103-12 354.8 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/01/2011

Labeler — Exact-Rx, Inc. (137953498)

Revised: 07/2021 Exact-Rx, Inc.