UNBLEM EST (BENZOYL PEROXIDE) CREAM [ELLI EST]

UNBLEM EST (BENZOYL PEROXIDE) CREAM [ELLI EST]
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NDC 42265-101-12
Set ID 3f0f7047-c1cf-4407-a1ff-26d9f5c8a05c
Category HUMAN OTC DRUG LABEL
Packager Elli Est
Generic Name
Product Class
Product Number
Application Number PART333D
  • ACTIVE INGREDIENT

    Active Ingredients: Benzoyl Peroxide 10%

  • PURPOSE

    Purpose: Acne Treatment

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: if
    swallowed, get medical help or contact
    a poison control center right away

  • INDICATIONS & USAGE

    Usage: For external use only.
    Do not use if: you have very sensitive
    skin are sensitive to benzoyl peroxide.

  • WARNINGS

    Warning: For external use only.
    Do not use if you- have very sensitive skin-are sensitive to benzoyl peroxide.
    Keep 0ut of reach of children. If swallowed, get medical help or contact a poison control center right away.
    When using this product -keep away from eyes, lips and mouth.-
    If contact occurs, flush thoroughly with water.- If going outside apply sunscreen after using this product.
    -If irritation or sensitivity develops, stop use of both products and ask a doctor.
    Avoid contact with hair or dyed fabric,including carpet and clothing which may be bleached by this product.
    -skin irritation may occur ,characterized by redness, burning , itching, peeling or possibly swelling.
    Mild irritation may be reduced by using the product less frequently or in a lower concentration. -If irritation becomes sever, discontinue use.
    If irritation still continues ,consult a doctor.
    -Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin.
    If this occurs only one medication should be used unless directed by a doctor

  • DOSAGE & ADMINISTRATION

    Directions: Cleanse the skin thoroughly before applying medication.- Cover the entire affected area with a thin layer 1 to 3 times daily.
    -If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    - Because of excessive drying of the skin may occur start with one application daily, then gradually increase to two or three times daily if needed or as
    directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water (Aqua), Polyacrylamide crosslinked 0.01-0.2 mole percent bisacrlyamid
    C-13-14 Isoparafin, laureth-7, Methylparaben, Propylparaben.

  • PRINCIPAL DISPLAY PANEL

    Elli'Est
    Unblem'Est
    Medicated Clarifying Lotion
    With 10% Benzoyl Peroxide
    1oz. / 28g.

    ndc42265-101-12

    ndc42265-101-12
    label image
    bpo1

  • INGREDIENTS AND APPEARANCE
    UNBLEM EST 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42265-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 840 mg  in 1 g
    POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494) 30 mg  in 1 g
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70) 15 mg  in 1 g
    Laureth-7 (UNII: Z95S6G8201) 10 mg  in 1 g
    Methylparaben (UNII: A2I8C7HI9T) 2.5 mg  in 1 g
    Propylparaben (UNII: Z8IX2SC1OH) 2.5 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42265-101-1228 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/25/2012
    Labeler - Elli Est (968164066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elli Est968164066manufacture(42265-101) , label(42265-101)

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