Label: ACTIOGEN ACNE DOTS TREATMENT- acne treatment patch

  • 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 14, 2015

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  • Active Ingredients

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne

  • DOSAGE & ADMINISTRATION

  • Warnings

    For external use only

  • When Using This Product

    Using other topical acne medication 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

  • Stop Using This Product 

    Discontinue use if you notice an redness, burning, or other forms of irritation

  • Do Not Use

    Do not use on broken skin or open wounds

  • Consult a physician

    Consult your physician in case of adverse reaction

  • Keep Out of Reach of Children

    Keep away from children

  • Other Information

    Store in a cool dry place.

  • Inactive Ingredients

    Acrylic adhesive, kollidon, 1,2 Propylene Glycol, Zinc Oxide

  • PRINCIPAL DISPLAY PANEL

    Front of box

    Front of Box

  • PRINCIPAL DISPLAY PANEL

    Back of Box

  • INGREDIENTS AND APPEARANCE
    ACTIOGEN ACNE DOTS TREATMENT 
    acne treatment patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69186-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S) 96 mg  in 100 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mg  in 100 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) 1 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69186-001-1010 in 1 BOX08/01/2014
    12 mg in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/01/2014
    Labeler - Actiogen Corp (967358057)
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