Label: ANTI-BLEMISH MATTE PRIMER- saliclylic acid lotion

  • 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 June 21, 2014

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  • PRINCIPAL DISPLAY PANEL

    Anti Blemish One Percent Unit Carton

  • PRINCIPAL DISPLAY PANEL

    Jouer

    Anti-blemish matte primer

    Base matifiante anti-imperfections

    SALICYLIC ACID ACNE TREATMENT

    NON DRYING NO IRRITATING PORE REFINER

    OIL FREE – HYPOALLERGENE-PARABEN FREE-SILICONE FREE

    30 mL / 1.0 fl. oz.

  • PRINCIPAL DISPLAY PANEL

    Jouer

    CONNECTIONG BEAUTY & STYLE

    Not tested on animals / non testes animaux- Distributed by / distribue par Jouer Cosmetics LLC- Los Angeles Ca 90024- Made in Canada / Fait en Canada

    WWW.JOUERCOSMETICS.COM

  • PRINCIPAL DISPLAY PANEL

    Anti-blemish matte primer

    This oil free mattifying anti-blemish primer, formulated with Salicylic Acid, penetrates into skin to help treat existing blemishes. Prevent development of new acne, and minimize the appearance of pores. Aloe, Vitamin E, Ginseng & Gingko Biloba Extract helps promote a shine-free, even complexion.

    For make-up application: Apply a pearl sized amount to clean skin to prime.

    OIL FREE-HYPOALLERGENIC-FRAGRANCE FREE-PARABEN FREE-SILICONE FREE-DERMATOLOGIST TESTED

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients                      

    Salicylic acid 1%

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses

    - for the treatment of acne.

    - dries and clears acne pimples, acne blemishes and blackheads and allows skin to heal.

    -helps prevent new acne pimples, acne blemishes and blackheads from forming.

  • BOXED WARNING (What is this?)

    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 all a time.

    -avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Cleanse skin thoroughly before applying. Cover the affected area with a thin layer 1 to 3 times a day. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 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.

  • OTHER SAFETY INFORMATION

    Other information

    -do not use this product if you have very sensitive skin of if you are sensitive to salicylic acid.

  • ADVERSE REACTIONS

    -you may report a serious adverse reaction to Jouer customer support, toll free: 1-800-315-5374, M-F, 8am-6pm PST (US & Canada only)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aqua (water / Eau), Ethylhexyl  Palmitate, Cetyl Alcohol, Tapioca Starch, Glycerin, Ceteareth-20, Glyceryl Stearate Se, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Hamamelis Virginiana (Witch Hazel) Water, Opuntia Ficus-indica Stem Extract, Biosaccharide Gum-1, Carbomer, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol

  • INGREDIENTS AND APPEARANCE
    ANTI-BLEMISH MATTE PRIMER 
    saliclylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69017-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
    OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
    GINKGO (UNII: 19FUJ2C58T)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69017-101-021 in 1 BOX
    1NDC:69017-101-0130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2014
    Labeler - Jouer Cosmetics LLC (011002088)
    Registrant - Jouer Cosmetics LLC (011002088)
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