SODIUM SULFACETAMIDE WASH 10%- sodium sulfacetamide liquid 
Gabar Health Sciences Corp.

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.

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Sodium Sulfacetamide Wash 10%

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.

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 known 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 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.

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.

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

label

SODIUM SULFACETAMIDE WASH 10% 
sodium sulfacetamide liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:82429-127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82429-127-16454 g in 1 BOTTLE; Type 0: Not a Combination Product04/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/05/2023
Labeler - Gabar Health Sciences Corp. (118401847)
Registrant - Gabar Health Sciences Corp. (118401847)

Revised: 1/2024
Document Id: 10188954-e610-71a1-e063-6294a90a34b2
Set id: 41c078df-fad4-4881-aad4-2719406dad1d
Version: 3
Effective Time: 20240129
 
Gabar Health Sciences Corp.