SODIUM SULFACETAMIDE WASH 10%- sodium sulfacetamide liquid

Sodium Sulfacetamide Wash 10% by

Drug Labeling and Warnings

Sodium Sulfacetamide Wash 10% by is a Prescription medication manufactured, distributed, or labeled by Gabar Health Sciences Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

INDICATIONS: Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis 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 known 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 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). See USP Controlled Room. Protect from freezing.

See bottle for lot number and expiration date.

SPL UNCLASSIFIED SECTION

Manufactured for and distributed by:
Gabar Health Sciences Corp
Atlanta, GA 30354

Adverse Reaction

Although rare, sodium sulfacetamide may cause local irritation.

Call your doctor for medical advice about side effects.

To report a serious adverse event or obtain product information, call 1-470-737-9424.

PRINCIPAL DISPLAY PANEL

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: 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.

HOW SUPPLIED: Sodium Sulfacetamide Wash 10% is available in a 16 fl oz (454g) bottle, NDC: 82429-127-16.

Manufactured for and distributed by Gabar Health Sciences Corp.

Atlanta, GA 30354

Rev 4/23

INGREDIENTS AND APPEARANCE

SODIUM SULFACETAMIDE WASH 10% 
sodium sulfacetamide liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 82429-127
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 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (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: 82429-127-16	454 g in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/05/2023

Labeler - Gabar Health Sciences Corp. (118401847)

Registrant - Gabar Health Sciences Corp. (118401847)