EXACT-RX SODIUM SULFACETAMIDE WASH 10%- sodium sulfacetamide 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.

----------

Exact-Rx Sodium Sulfacetamide Wash 10%

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: 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, and sodium thiosulfate.

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

Description: Each gram contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: 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, and sodium thiosulfate.

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

image description

EXACT-RX SODIUM SULFACETAMIDE WASH 10%
sodium sulfacetamide liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:42808-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)	SULFACETAMIDE SODIUM	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM THIOSULFATE (UNII: HX1032V43M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42808-102-06	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2011	08/01/2011
2	NDC:42808-102-12	354.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2011	08/01/2011

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

Labeler - Exact-Rx, Inc. (137953498)

Name	Address	ID/FEI	Business Operations
Establishment
Exact-Rx, Inc.		137953498	repack(42808-102)

Revised: 12/2019

Document Id: 990d05c4-cf4d-562f-e053-2995a90a2dc9

Set id: ef8af202-4b80-460f-a392-09508f55add9

Version: 3

Effective Time: 20191206

Exact-Rx, Inc.