EXACT-RX SODIUM SULFACETAMIDE AND SULFER 10%/5% CLEANSER- sodium sulfacetamide, sulfer lotion 
Exact-Rx, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS: Sodium Sulfacetemide 10% and Sulfer 5% Cleanser

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

seborrheic dermatitis.

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.

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR

OPHTHALMIC USE. (KEEP AWAY FROM EYES).

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:  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 %%

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

CAUTION: If redness or irritaiton occurs, discontinue use.

Each gram contains 100 mg of sodium sulfacetamide USP in a

vehicle consisting of: 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, and sodium thiosulfate.

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

See bottle for lot number and expiration date

Manufactured in the U.S.A. for

Exact-Rx, Inc., Melville, NY 11747

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-101-205-00
Iss:12/16

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EXACT-RX SODIUM SULFACETAMIDE AND SULFER 10%/5% CLEANSER 
sodium sulfacetamide, sulfer lotion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42808-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM100 mg  in 1 g
FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
SODIUM THIOSULFATE (UNII: HX1032V43M)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42808-112-06170 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2011
2NDC:42808-112-12340 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/201104/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/201104/20/2017
Labeler - Exact-Rx, Inc. (137953498)
Establishment
NameAddressID/FEIBusiness Operations
Exact-Rx, Inc.137953498repack(42808-112)

Revised: 4/2017
 
Exact-Rx, Inc.