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Blemish by Kamins Dermatologics Inc.

Medically reviewed on October 19, 2017

Dosage form: gel
Ingredients: BENZOYL PEROXIDE 50mg in 1mL
Labeler: Kamins Dermatologics Inc.
NDC Code: 63550-193

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.

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 02248217

BLEMISH 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-193
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ACER SACCHARUM SAP 
DIMETHICONE 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
SORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:63550-193-2330 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/FEIOperations
Kamins Dermatologics Inc.254050784manufacture, pack, label

 
Kamins Dermatologics Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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