Sodium Sulfacetamide

Manufacturer
Method Pharmaceuticals, LLC
Effective date
2026-02-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 22:06:00

Label at a glance#

ProductSodium Sulfacetamide
Active ingredientSULFACETAMIDE SODIUM
Label structure10 sections

Dosage and administration

Seborrheic dermatitis including seborrhea sicca - Wash affected areas twice daily (morning and evening) or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly, pat dry and repeat after 10 to 20 seconds. Rinsing with plain water will remove any excess medication. Repeat...

Storage and handling

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing and excessive heat. Keep bottle tightly closed. This bottle is not filled to the top but does contain 6 fl oz of product as identified on the front panel of the bottle. To report a serious adverse event or obtain product information, call (877) 250-3427.

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butylated Hydroxytoluene, Citric Acid, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.

Description

DESCRIPTION SECTION

Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of:
Butylated Hydroxytoluene, Citric Acid, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.

Indications

INDICATIONS & USAGE SECTION

This product 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

CONTRAINDICATIONS SECTION

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Seborrheic dermatitis including seborrhea sicca - Wash affected areas twice daily (morning and evening) or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly, pat dry and repeat after 10 to 20 seconds. Rinsing with plain water will remove any excess medication. Repeat application as described above for 8 to 10 days or as directed by your physician. lf skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following the use of this product is not necessary, but the hair should be shampooed at least once a week. As the condition subsides, the interval between
applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of this product should be reinitiated as at the beginning of treatment.


Secondary cutaneous bacterial infections - Wash affected areas twice daily (morning and evening) or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10 to 20 seconds working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described above for 8 to 10 days or as directed by your physician. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. See package insert for full prescribing information.

Warnings

WARNINGS SECTION

WARNING: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
KEEP OUT OF REACH OF CHILDREN.

Avoid contact with eyes, lips and mucous membranes.


See label booklet for Full prescribing information.

Storage

STORAGE AND HANDLING SECTION

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing and excessive heat. Keep bottle tightly closed.


This bottle is not filled to the top but does contain 6 fl oz of product as identified on the front
panel of the bottle.

To report a serious adverse event or obtain product information, call (877) 250-3427.

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Manufactured in the U.S.A. for

Method Pharmaceuticals, LLC

Southlake, Texas 76092

Rev 09/21

Package 12oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

Package 16 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSN7
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCD7
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SULFACETAMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-477-06Sodium Sulfacetamide177 g in 1 BOTTLELIQUID1777
58657-477-12Sodium Sulfacetamide355 g in 1 BOTTLELIQUID3557
58657-477-16Sodium Sulfacetamide480 g in 1 BOTTLELIQUID4807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-477-06GM - Gram58657-477069c9e74-b394-4c1e-a476-b7b0a436620c12022-04-06
58657-477-12GM - Gram58657-477f583e409-ea67-45c2-a1f4-30e56bf7225912022-04-06
58657-477-16GM - Gram58657-477cb146c33-42ff-4bb0-bd13-123f5d06163212022-04-06

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58657-47758657-477-12, 58657-477-16, 58657-477-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-10-21monthly-update2026-06-03 17:43:44
52024-11-20full-release2026-05-31 21:18:04

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
Sodium SulfacetamideSODIUM SULFACETAMIDEMethod Pharmaceuticals, LLCd65e777b-682b-732d-e053-2a95a90a41ad2026-02-12WarningsExact identifier
ndc (package): 58657-477-12
ndc (package): 58657-477-16
ndc (package): 58657-477-06
ndc (product): 58657-477
ndc11 (package): 58657047712
ndc11 (package): 58657047716
ndc11 (package): 58657047706
spl id: 4aad445c-77e0-b8cd-e063-6394a90afd06
spl set id: d65e777b-682b-732d-e053-2a95a90a41ad

Reported adverse events (FAERS/openFDA)#

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