IBLANC RESTORA-BRIGHT ACNE HEALING (BENZOYL PEROXIDE) CREAM [IBLANC INC.]

IBLANC RESTORA-BRIGHT ACNE HEALING (BENZOYL PEROXIDE) CREAM [IBLANC INC.]
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NDC 52960-101-12
Set ID 21e041cb-ef57-47f4-a3c9-692e22c510db
Category HUMAN OTC DRUG LABEL
Packager iBlanc Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
  • 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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