Label: BOTANIC SKINCARE ACNE DEFENSE TREATMENT- salicylic acid lotion

  • NDC Code(s): 69735-637-30
  • Packager: ElleGreen Health & Beauty Shop LLC
  • 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 February 23, 2017

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  • Active Ingredient

    Salicylic Acid 2.00%

    Acne Treatment

  • Use For:

    For the treatment of Acne.

    Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishen from forming.

  • Warnings

    • For external use only.
    • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
    • 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 per day.

    Do not use

    for prolonged periods without consulting a doctor

    Keep out of reach of children

    If swallowed, contact physician or poison control center immediately.

    Store at room temperature.

  • Directions

    Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body.

    • For best results apply one to three times per day.
  • Other Ingredients

    ALLANTOIN, ALOE BARBADENSIS LEAF (ALOE VERA GEL) JUICE, AQUA (DEIONIZED WATER), BUTYLENE GLYCOL, CAMELLIA SINENSIS (GREEN TEA) EXTRACT, CAMELLIA SINENSIS (WHITE TEA) EXTRACT, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, CETYL ALCOHOL, DIMETHICONE,
    DMAE BITARTRATE, EMU OIL, GLYCERIN, GLYCRRHIZA GLABRA (LICORICE) EXTRACT, HYALURONIC ACID, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, METHYLISOTHIAZOLINONE, POLYSORBATE-20, SODIUM PCA, XANTHAN GUM

  • Product Label

    Botanic Skincare Acne Defense Treatment

  • INGREDIENTS AND APPEARANCE
    BOTANIC SKINCARE ACNE DEFENSE TREATMENT 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69735-637
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DEANOL BITARTRATE (UNII: D240J05W14)  
    EMU OIL (UNII: 344821WD61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69735-637-301 in 1 CARTON02/22/2017
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/19/2015
    Labeler - ElleGreen Health & Beauty Shop LLC (079760751)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(69735-637)