Sodium Sulfacetamide

Manufacturer
Bryant Ranch Prepack
Effective date
2024-12-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
100
Source
full-release
Hydrated at
2026-05-31 21:20:43

Label at a glance#

ProductSodium Sulfacetamide
Active ingredientSULFACETAMIDE SODIUM
Label structure9 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.

HOW SUPPLIED

How Supplied Section

Sodium Sulfacetamide 10%

  • NDC 72162-1665-2: 355 g in a BOTTLE
  • NDC 72162-1665-4: 480 g in a BOTTLE
  • NDC 72162-1665-7: 177 g in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Sulfacetamide 10%

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSN100
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCD100
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSY100

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
72162-1665-2Sodium Sulfacetamide355 g in 1 BOTTLELIQUID355100
72162-1665-4Sodium Sulfacetamide480 g in 1 BOTTLELIQUID480100
72162-1665-7Sodium Sulfacetamide177 g in 1 BOTTLELIQUID177100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1665SODIUM SULFACETAMIDE LIQUID [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20241228_acd3fb4a-558d-4565-84d8-23a0d917eab6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1665-2GM - Gram72162-16650c1c2050-0968-49db-adda-60879ca3898c12025-02-10
72162-1665-4GM - Gram72162-166576b2b5a2-c1c9-4657-a046-7662ff3cfd9812025-02-10
72162-1665-7GM - Gram72162-16657e98abd6-1edf-47aa-ad37-981dac3b8a3912025-02-10
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
72162-166572162-1665-2, 72162-1665-4, 72162-1665-7
58657-477

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

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 · 2 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 (product): 58657-477
Sodium SulfacetamideSODIUM SULFACETAMIDEBryant Ranch Prepackacd3fb4a-558d-4565-84d8-23a0d917eab62024-12-24WarningsExact identifier
ndc (package): 72162-1665-4
ndc (package): 72162-1665-2
ndc (package): 72162-1665-7
ndc (product): 72162-1665
ndc11 (package): 72162166504
ndc11 (package): 72162166502
ndc11 (package): 72162166507
spl id: 233623bf-3ee7-437d-a8e6-1a71bc16f299
spl set id: acd3fb4a-558d-4565-84d8-23a0d917eab6

Reported adverse events (FAERS/openFDA)#

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