INTENSIVE FACE AND BODY ACNE TREATMENT- benzoyl peroxide gel 
DR LIN SKINCARE

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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ACTIVE INGREDIENT

BENZYL PEROXIDE 10%

PURPOSE

ACNE TREATMENT

USE

FOR THE TREATMENT OF ACNE AND ACNE DARK AND RED MARKS.

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE THIS MEDICATION IF YOU

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

When using this product

STOP USE AND ASK A DOCTOR IF IRRITATION BECOMES SEVERE.

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

Other information

INACTIVE INGREDIENTS

Water, Sodium C14-16 Olefin Sulfonate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Aloe Barabadensis Leaf Extract, Sodium PCA, Allantoin, Panthenol, Phenoxyethanol, Methylisothiazolinone, Citrus Arantium Bergamia (Bergamot) Fruit Extract, Sodium Hydroxide

QUESTIONS OR COMMENTS?

1-877-445-4624

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DLSC_6ozIntensiveFaceBody_proofR1

INTENSIVE FACE AND BODY ACNE TREATMENT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58876-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ALLANTOIN (UNII: 344S277G0Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
BERGAMOT ORANGE (UNII: IET5D90X0D)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58876-107-36180 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/11/2014
Labeler - DR LIN SKINCARE (622329980)
Establishment
NameAddressID/FEIBusiness Operations
Westwood Laboratories Inc.069926483manufacture(58876-107) , pack(58876-107)

Revised: 7/2014
Document Id: 8c7e10d0-e160-430e-8ef8-4ef95b7e1c13
Set id: 94737c23-350d-4d36-8521-d1b9e52fbb55
Version: 1
Effective Time: 20140711
 
DR LIN SKINCARE