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Name:Blemish
Manufacturer:Kamins Dermatologics Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BLEMISH GEL 5% CONSUMER LABELING

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 5% CONSUMER LABELING

Active ingredients:

Benzoyl Peroxide: 5%

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

  • broken skin.
  • large areas of the body.

When using this product,

  • Apply to affected areas only
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with eyes/eye area, lips, mouth and nostrils.  If contact occurs, rinse thoroughly with water.
  • This product may bleach hair or dyed fabrics.
  • Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin.  Only one drug should be used unless directed by a doctor.

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

  • Clean the skin thoroughly befor applying.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, use a sunscreen.  Allow medicated acne gel to dry, then follow directions on the sunscreen labeling.

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 5%

30mL / 1.7 fl.oz

DIN 02248217Blemish front panel image


BLEMISH 
benzoyl peroxide gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-193
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
ACER SACCHARUM SAP  
DIMETHICONE  
SODIUM HYDROXIDE  
PHENOXYETHANOL  
CAPRYLYL GLYCOL  
SORBIC ACID  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63550-193-23 30 mL in 1 BOX None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 10/19/2010

Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Kamins Dermatologics Inc. (254050784)
Establishment
Name Address ID/FEI Operations
Kamins Dermatologics Inc. 254050784 manufacture, pack, label

Revised: 10/2010 Kamins Dermatologics Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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