Label: ACNI SPOT liquid

  • 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 May 24, 2010

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  • ACTIVE INGREDIENT

    Salicylic Acid 2% Acne Treatment

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, immediately flush with water.

  • WARNINGS

    Warnings: Forexternal use only.
    Do not use if using other topical acne medications at the same time or immediately
    following use of this product as it may increase dryness or irritation of the skin. If
    this occurs, only one medication should be used unless directed by a physician.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Directions:
    Cleanse the skin thoroughly before applying medication. Cover the entire affected area
    with a thin layer one to three times dally. Because excessive drying of the skin may occur,
    start with one application daily, then gradually increase to two or three 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.

  • INACTIVE INGREDIENT

    Other lngredients: Water, SD AlcohoI40-B. Glycolic Acid, Urea, Propylene
    Glycol, Ammonium Glycolate, Allantoin, Bisabolol, Nonoxynol-9. Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    pictures
    Label Front
    Label Back
  • INGREDIENTS AND APPEARANCE
    ACNI SPOT 
    acni spot liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35658-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1.93 mL  in 96.5 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35658-000-0325 in 1 CASE
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2009
    Labeler - La Jolla (021918650)
    Registrant - Harmony Labs, Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack
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