RENU LABORATORIES ACNE SULPHUR L- acne sulfur lotion suspension 
Renu Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sulfur Lotion

Active Ingredient

Sulfur Colloidal (10%)

Purpose

Topical Acne Treatment

Uses

Warnings

For external use only

Do Not Use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Camphor, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminum Silicate, Salicylic Acid, Zinc Oxide.

Renu Sulfur Lotion

RENU LABORATORIES ACNE SULPHUR L 
acne sulfur lotion suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1.4 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
WATER (UNII: 059QF0KO0R)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Product Characteristics
Colorwhite (Suspension) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-450-0256 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/16/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/16/2015
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-450)

Revised: 1/2022
Document Id: d5c9e15b-7e88-d9a5-e053-2995a90a9725
Set id: 13de0e4c-b134-41c0-e054-00144ff88e88
Version: 5
Effective Time: 20220117
 
Renu Laboratories, Inc.