Label: BLEMISH- benzoyl peroxide gel

  • NDC Code(s): 63550-193-23
  • Packager: Kamins Dermatologics Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 30, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient:

    Benzoyl Peroxide: 5%

  • PURPOSE

    Purpose: Acne treatment

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    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

    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.

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    B. KAMINS

    BLEMISH GEL 5%

    30mL / 1.7 fl.oz

    DIN 02248217 Blemish front panel image

  • INGREDIENTS AND APPEARANCE
    BLEMISH 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-193
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 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:63550-193-2330 mL in 1 BOX; Type 0: Not a Combination Product10/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2010
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Odan Laboratories Ltd208585604manufacture(63550-193) , pack(63550-193)