Label: OIL-FREE ACNE WASH FOAMING SCRUB- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL

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 November 12, 2013

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  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Indications

    • for the treatment of acne
  • Warnings

    For external use only.

    Using other topical acne medications at the same time or immediately following 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.

  • Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Avoid contact with eyes.

    If contact occurs, flush thoroughly with water.

  • Directions

    • Clean twice daily
    • Gently massage onto wet face, add water and work into a lather
    • Rinse thoroughly
  • Inactive ingredients

    water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, acrylates copolymer, glycerin, nylon-6, fragrance, sodium hydroxide, propylene glycol, polyquaternium-7, citric acid, polysorbate 20, C12-15 alkyl lactate, linoleamidopropyl PG-dimonium chloride phosphate, propylene glycol, cocamidopropyl PG-dimonium chloride phosphate, benzalkonium chloride, chamomilla recutita (matricaria) flower extract, citrus grandis (grapefruit) fruit extract, aloe barbadensis leaf juice, mannitol, cellulose, mica, retinyl palmitate, tocopheryl acetate (vitamin E), acrylates/ammonium methacrylate copolymer, talc, triethyl citrate, titanium dioxide, hydroxypropyl methylcellulose, disodium EDTA, ascorbyl palmitate, ultramarines, red 30, red 33

  • Package/Label Principal Display Panel

    America*s Choice 
    oil-free acne wash
    foaming scrub

    acne treatment with salicylic acid

    clears up breakouts

    *Compare to Neutrogena Oil-Free Acne Wash
    Pink Grapefruit Foaming Scrub ingredients

    100% Chamomile Extract & Natural Grapefruit

    4.2 Fl Oz (124 mL)

     Distributed by Onpoint, Inc.
    2 Paragon Drive
    Montvale, NJ 07645
    ©2013 All Rights Reserved.

    Manufactured in Israel 3D775 0A T1

    *This product is not manufactured or distributed by Neutrogena® owner of the Oil-Free Acne Wash Pink Grapefruit Foaming Scrub.

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    OIL-FREE ACNE WASH FOAMING SCRUB 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-775
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PUMMELO (UNII: ET1TN5W71X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MICA (UNII: V8A1AW0880)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42421-775-11124 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/05/2013
    Labeler - Emilia Personal Care Inc. (965445112)
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