BLEMISH - benzoyl peroxide gel 
Kamins Dermatologics 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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BLEMISH GEL 10% CONSUMER LABELING

Active ingredients:

Benzoyl Peroxide: 10%

Purpose: Acne Treatment

Keep out of children’s reach.

A unique oil-free, color-free benzoyl peroxide gel that helps to gently clear blemishes, blackheads and spots.  Also contains our moisturizing Bio-Maple compound, which helps prevent skin from becoming excessively dry.

Uses

■ Helps treat acne.

■ Dries up acne pimples.

■ Helps prevent new acne pimples.

Warnings

For external use only.

Do not use on

When using this product,

Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Directions

INACTIVE INGREDIENTS: water, alcohol denat., acer saccharum (maple isolate), disodium PEG-12 dimethicone sulfosuccinate, carbomer, sodium hydroxide, phenoxyethanol, caprylyl glycol, sorbic acid

B. KAMINS

BLEMISH GEL 10%

30mL / 1.7 fl.ozBLEMISH GEL  front panel image

BLEMISH 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-194
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ACER SACCHARUM SAP (UNII: 75UOH57984)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63550-194-2330 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D10/19/2010
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Kamins Dermatologics Inc. (254050784)
Establishment
NameAddressID/FEIBusiness Operations
Kamins Dermatologics Inc.254050784manufacture, pack, label

Revised: 10/2010
Document Id: 75dc31bc-4d3f-482d-abd3-d60cdddcf89d
Set id: ffb0097e-eeca-4b89-9a11-975091255e5a
Version: 1
Effective Time: 20101019
 
Kamins Dermatologics Inc.