Sodium Sulfacetamide Wash 10%

Sodium Sulfacetamide Wash 10%
SPL v2
SPL
SPL Set ID abd554b9-bf1f-4494-bc2a-ecae5500bb23
Route
TOPICAL
Published
Effective Date 2024-01-29
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfacetamide (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Cocamidopropyl Betaine Edetate Disodium Glyceryl Monostearate Methylparaben Caprylocaproyl Polyoxylglycerides 6 Peg-60 Almond Glycerides Peg-150 Pentaerythrityl Tetrastearate Polysorbate 60 Water Sodium Lauryl Sulfate Sodium Thiosulfate Xanthan Gum

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-10-20

Description

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.


Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES).

Indications and 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 and 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.

Contraindications

CONTRAINDICATIONS:Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides.

Description

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.

Section 34084-4

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.

Section 42229-5

Manufactured for and distributed by:

Gabar Health Sciences Corp

Atlanta, GA 30354

Section 44425-7

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.

Section 51727-6

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.

Section 51945-4

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


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

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.

Contraindications (34070-3)

CONTRAINDICATIONS:Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides.

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES).

Section 34084-4 (34084-4)

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.

Section 42229-5 (42229-5)

Manufactured for and distributed by:

Gabar Health Sciences Corp

Atlanta, GA 30354

Section 44425-7 (44425-7)

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.

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

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


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