FDA Label for Sodium Sulfacetamide Wash 10%
View Indications, Usage & Precautions
Sodium Sulfacetamide Wash 10% Product Label
The following document was submitted to the FDA by the labeler of this product Gabar Health Sciences Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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).
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
Other
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.
Package Label.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: ammonium lauryl sulfate, butylated hydroxytoluene, ceteareth-25, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, guar gum, methylparaben, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.
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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