Sodium Sulfacetamide Wash 10%
Sodium Sulfacetamide Wash 10%
abd554b9-bf1f-4494-bc2a-ecae5500bb23
HUMAN PRESCRIPTION DRUG LABEL
Jan 29, 2024
Gabar Health Sciences Corp.
DUNS: 118401847
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM SULFACETAMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
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: 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 8 fl oz (227g) bottle, NDC 82429-127-08.
Manufactured for and distributed by Gabar Health Sciences Corp.
Atlanta, GA 30354
Rev 4/23
INDICATIONS & USAGE SECTION
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.
CONTRAINDICATIONS SECTION
**CONTRAINDICATIONS:**Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides.
ADVERSE REACTIONS SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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.
INACTIVE INGREDIENT SECTION
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 SECTION
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