Label: IBLANC RESTORA-BRIGHT ACNE HEALING- benzoyl peroxide cream

  • 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 August 18, 2012

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  • INDICATIONS & USAGE

    USES: FOR THE TREATMENT OF ACNE
  • ACTIVE INGREDIENT

    Active Ingredient:   Benzoyl Peroxide 5.25%

  • PURPOSE

    Uses

    • for the treatment of acne
  • WARNINGS

    Warnings

    For external use only

    When using this product
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
  • DO NOT USE

    Do not use if you

    • have very sensitive skin.
    • are sensitive to benzoyl peroxide
  • WHEN USING

    When using this product

    • avoid unnecessary skin exposure and use a sunscreen
    • avoid contact with eyes, lips and mouth.  If eye contact accidentally occurs, rinse eyes throughly with water.
    • avoid contact with hair and dyed fabrics which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration.

    Stop use and ask a doctor if irritation becomes severe.

  • INACTIVE INGREDIENT

    Inactive Ingredients Aqua (Water), Glycerin, Allantoin, Aloe Barbadensis Leaf Juice Powder, Acrylates/C13-30 Alkyl Acrylate Crosspolymer, Sorbitol, Sodium Hydroxide, Caprylyl Glycol, Phenoxyethanol

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    iBlanc Dermaceuticals

    RESTORA-BRIGHT
    ACNE-HEALING
    CREAM
    Acne Healing Cream ART 2012-08-01_LBL

  • DOSAGE & ADMINISTRATION

    APPLY A THIN LAYER TO BLEMISHES DAILY AFTER CLEANSING SKIN. IF NEEDED AND NO DRYNESS OR PEELING OCCURS, USE FOR TOUCH-UP THROUGHOUT THE DAY.
  • INGREDIENTS AND APPEARANCE
    IBLANC RESTORA-BRIGHT  ACNE HEALING
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52960-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide5.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Allantoin (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Carbomer Copolymer TYPE A (UNII: 71DD5V995L)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52960-101-1245 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/01/2012
    Labeler - iBlanc Inc. (078510606)
    Registrant - iBlanc Inc. (078510606)
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