Label: ALBA ACNEDOTE CLEAN TREAT TOWELETTE- salicylic acid cloth

  • 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 November 18, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 2.0%

  • DOSAGE & ADMINISTRATION

    Wipe face and neck to remove makeup, oil, grime and other pore clogging impurities. Avoid eye area. Do not rinse. Because drying of the skin may occur, start with one application daily and gadually increase to two or three times daily if needed or directed by doctor. If bothersome dryness or peeling occurs, reduce frequency of application.

  • PURPOSE

    Acne Treatment

  • WARNINGS

    For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

  • INACTIVE INGREDIENT

    Water, Propanediol, Caprylic/Capric Triglyceride, C14-22 Alcohols, Sodium Cetearyl Sulfate,, Aloe Barbadensis Leaf Juice(1), Hamamelis Verginiana (Witch Hazel) Water, Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Carum Petroselinum (Parsley) Extract, Glycyrrhiza Glabra (Licorice) Roo Exxtract, Salix Alba (Willow) Bark Extract (1),Citrus Aurantium Dulcis (Orange) Peel Oil (2), Citrus Aurantium Bergamia (Bergamot) Oil (2), Mentha Piperita (Peppermint) Oil (2), C12-20 Alkyl Glucoside, Cetearyl Alcohol, Citric Acid, Glycerin, Potassium Hydroxude, Xanthan Gum, Benzoic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

    (1) Certified Organicf Ingredient; (2) For scent only

  • INDICATIONS & USAGE

    For the treatment of acne.

  • PRINCIPAL DISPLAY PANEL

    pouch label

  • INGREDIENTS AND APPEARANCE
    ALBA ACNEDOTE CLEAN TREAT TOWELETTE 
    salicylic acid cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2765
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 30 
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    PARSLEY (UNII: 58FMD0Q0EV)  
    CHAMOMILE (UNII: FGL3685T2X)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2765-430 in 1 POUCH; Type 0: Not a Combination Product11/26/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/26/2013
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Registrant - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture(61995-2765)