Label: ALBA NATURAL ACNEDOTE- salicylic 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 July 21, 2010

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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. 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.

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • QUESTIONS

    QUESTIONS?

    Call (888) 659-7730 or visit www.AlbaBotanica.com

    The Hain Celestial Group, Inc.

    Melville, NY 11747

    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL

             image of carton label

  • INGREDIENTS AND APPEARANCE
    ALBA NATURAL ACNEDOTE  
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2762
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2.0 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2762-21 in 1 CARTON
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33302/18/2010
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture
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