Sodium Sulfacetamide Wash 10%

Manufacturer
Gabar Health Sciences Corp.
Effective date
2024-01-29
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:12:09

Label at a glance#

ProductSodium Sulfacetamide Wash 10%
Active ingredientSULFACETAMIDE SODIUM
Label structure10 sections

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.

Label contents#

Full prescribing information#

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.

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

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

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.

CONTRAINDICATIONS SECTION

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

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

Adverse Reaction

ADVERSE REACTIONS SECTION

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: 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

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82429-127SODIUM SULFACETAMIDE WASH 10% (SODIUM SULFACETAMIDE) LIQUID [GABAR HEALTH SCIENCES CORP.]2Unmatched20240131_abd554b9-bf1f-4494-bc2a-ecae5500bb23.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82429-127-08GM - Gram82429-12721195847-0de7-4e8c-94da-e0115d76110a12024-01-04
82429-127-16GM - Gram82429-1272d7c1e97-f969-4352-a3de-bfe040fea5bd12023-05-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82429-12782429-127-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4c2e385a-596b-f3ef-e063-6394a90afc56abd554b9-bf1f-4494-bc2a-ecae5500bb232026-03-04Warnings, Adverse reactionsExact identifier
spl set id: abd554b9-bf1f-4494-bc2a-ecae5500bb23

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.