Exact-Rx SODIUM SULFACETAMIDE and SULFER 10%/5% Cleanser

Manufacturer
Exact-Rx, Inc.
Effective date
2025-12-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
13
Source
monthly-update
Hydrated at
2026-06-03 17:48:03

Label at a glance#

ProductExact-Rx SODIUM SULFACETAMIDE and SULFER 10%/5% Cleanser
Active ingredientSULFACETAMIDE SODIUM, SULFUR
Label structure10 sections

Storage and handling

Store at 20 to 25C (68 to 77F). See USP Controlled Room Temperature. Protect from freezing. See bottle for lot number and expiration date

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS: Sodium Sulfacetemide 10% and Sulfer 5% Cleanser

is indicated for he topical control of acne vulgaris, acne rosacea and

seborrheic dermatitis.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS FOR USE: Wash affected area once or twice daily, or

as directed by your physician. Avoid contat with eyes or mucous

membranes. Wet skin and liberally apply to areas to be cleansed,

massage gently into skin for 10-20 seconds working into a full lather, rinse

thoroughly and pat dry. if drying occurs, it may be controlled by rinsing

cleanser off sooner or using less often. 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% & Sulfer 5% Cleanser is

contraindicated in persons with know or suspected hypersensitivity to sulfonamides,

sulfer or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfer %5%

Cleanser is not to be used by patients with kidney disease.

CAUTION: If redness or irritaiton occurs, discontinue use.

INACTIVE INGREDIENT SECTION

77

STORAGE AND HANDLING SECTION

Store at 20 to 25C (68 to 77F). See USP Controlled Room Temperature. Protect from freezing.

See bottle for lot number and expiration date

DESCRIPTION SECTION

Manufactured in the U.S.A. for

Exact-Rx, Inc., Melville, NY 11747

SPL PATIENT PACKAGE INSERT SECTION

44

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5566

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42808-113-06GM - Gram42808-1134fc25d58-0e15-4024-a856-08122d64152112017-03-06
42808-113-12GM - Gram42808-1136c0d6043-5aad-481c-adcb-4bed6a77df9c12017-03-06

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42808-11342808-113-06, 42808-113-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML · Source PDF

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
4ab89a09-f11f-407a-e063-6394a90a946cbbacc6fe-5627-4126-b26d-2a550d304f8e2026-02-13WarningsExact identifier
spl set id: bbacc6fe-5627-4126-b26d-2a550d304f8e

Reported adverse events (FAERS/openFDA)#

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