Label: ALBA BOTANICA ACNEDOTE OIL CONTROL- salicylic acid lotion

  • NDC Code(s): 61995-2062-2
  • Packager: The Hain Celestial Group, Inc.
  • 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 April 12, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    Salicylic Acid 2.0%

  • INDICATIONS & USAGE

    USE

    • For the treatment of acne
    • Apply to freshly cleansed face morning and evening
    • For the best results, use after Alba Botanica Natural ACNEdote Deep Clean Astringent
  • WARNINGS

    WARNINGS

    For external use only.

    Avoid direct contact with eyes. If contact occurs, flush thoroughly with water.

  • 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

  • INACTIVE INGREDIENT

    water, Ethylhexyl Stearate,Cetearyl Alcohol, Glycerin, Cetyl Alcohol, Dimethicone, Cetearyl Olivate, Sorbitan Olivate, Polysorbate 60, Azadirachta Indica Leaf Extract (1), Camellia Sinensis Leaf Extract (1), Carum Petroselinum (Parsley) Extract, Melissa Officinalis Leaf Extract, Salix Alba (Willow) Bark Extract, Urtica Dioica (Nettle) Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil (2), Citrus Aurantium Dulcis (Orange) Peel Oil (2), Mentha Piperita (Peppermint) Oil (2), Potassium Hydroxide, Xanthan Gum, Alcohol (1), Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol.

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

  • DOSAGE & ADMINISTRATION

    Using other topical acne medications 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 drug should be used unless directed by a doctor.

  • PRINCIPAL DISPLAY PANEL

    AL00762 Label

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA ACNEDOTE OIL CONTROL 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    WILLOW BARK (UNII: S883J9JDYX)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PARSLEY (UNII: 58FMD0Q0EV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2062-21 in 1 CARTON08/06/2015
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/06/2015
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-2062)