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

Exact-Rx Sodium Sulfacetamide Wash 10% by

Drug Labeling and Warnings

Exact-Rx Sodium Sulfacetamide Wash 10% by is a Prescription medication manufactured, distributed, or labeled by Exact-Rx, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

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.

WARNINGS

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR

OPHTHALMIC USE. (KEEP AWAY FROM EYES).

WARNINGS

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

CONTRAINDICATIONS: Sodium Sulfacetamide 10% Wash is

contraindicated in persons with know or suspected hypersensitivity to sulfonamides.

INACTIVE INGREDIENT

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.

STORAGE AND HANDLING

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

DESCRIPTION

Manufactured in the U.S.A. for

Exact-Rx, Inc., Melville, NY 11747

PATIENT PACKAGE INSERT

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: 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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM THIOSULFATE (UNII: HX1032V43M)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42808-103-06	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2011
2	NDC: 42808-103-12	354.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2011

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)

Establishment
Name	Address	ID/FEI	Business Operations
Exact-Rx, Inc.		137953498	repack(42808-103)