Label: NATURAL PEELING TRIACTIVE ACNE- 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 November 1, 2016

If you are a consumer or patient please visit this version.

  • ASK DOCTOR

    Stop use and ask a doctor if rash occurs

    Children under 6 months: ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

    . keep out of reach of children

  • Questions or Comments?

    Questions or comments? + 34 961 501 099 M-F 9:00 am to 5:00 pm

  • OTHER SAFETY INFORMATION

    . keep the product in a cool and dry place

  • Directions

    . clean the skin thoroughly before applying this product

    . cover the entire affected area with a thin layer one to three times daily, massage the area and rinse thoroughly.

    . because excessive dryness 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

  • DOSAGE & ADMINISTRATION

    . clean the skin thoroughly before applying this product

    . cover the entire affected area with a thin layer one to three times daily, massage the area and rinse thoroughly.

    . because excessive dryness 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

  • Uses

    . helps keep the skin clear of new blakcheads

  • PURPOSE

    . acne treatment lotion

    . helps the skin clear of new blackheads

  • Active Ingredients

    Salicylic acid 0.5%........................... Acne Treatment

  • WARNINGS

    For external use only.

    Do not use on damaged or broken skin.

    Avoid use around the eyes

    Do not sunbathe after application

    Stop use and ask a doctor if rash occurs.

    Children under 6 months: as a doctor.

    KEEP OUT OF THE REACH OF CHILDREN

    USING OTHER TOPICAL ACNE DRUGS AT THE SAME TIME OR INMEDIATELY FOLLOWING THE 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

  • Sensitive Test for a New User

    Apply product sparingly to one or two small affected areas during the first three days. If not discomfort occurs follow the directions state above in this label.

  • INACTIVE INGREDIENT

    water, propylene glycol, glycolic acid, sodium hydroxide, lactic acid, carbomer 934, fragrance.

    Bottle 2

  • PRINCIPAL DISPLAY PANEL

    Natural Peeling Tri Active

    Acne Treatment Lotion

    Intelligent Technology

    Rgnerin Three Action Cleaner

    Facial Collection

    Bottle 1

  • INGREDIENTS AND APPEARANCE
    NATURAL PEELING TRIACTIVE ACNE 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 48.5 mg  in 1 mL
    PERFLUNAFENE (UNII: 54A06VV62N) 0.1 mg  in 1 mL
    CARBOMER 934 (UNII: Z135WT9208) 1.5 mg  in 1 mL
    PROPANEDIOL (UNII: 5965N8W85T) 40 mg  in 1 mL
    GLYCOLIC ACID (UNII: 0WT12SX38S) 5.6 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 2 mg  in 1 mL
    LACTIC ACID (UNII: 33X04XA5AT) 1.8 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-077-01500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/03/2016
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casmara Cosmetics, SA464973544manufacture(20151-077)