Label: SODIUM SULFACETAMIDE WASH 10%- sodium sulfacetamide liquid
- NDC Code(s): 82429-127-16
- Packager: Gabar Health Sciences Corp.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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.
Drug Label Information
Updated January 29, 2024
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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
- WARNINGS
- WARNINGS
- CONTRAINDICATIONS
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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
- SPL UNCLASSIFIED SECTION
- Adverse Reaction
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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
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INGREDIENTS AND APPEARANCE
SODIUM SULFACETAMIDE WASH 10%
sodium sulfacetamide liquidProduct 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)