Label: NATUROPATHICA CHILL CHOCOLATE VINE DETOX TONIC- 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 30, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Use

    For treatment of acne

  • Warning

    For external use only

    Ask a doctor or pharmacist before use if you are using other topical acne products at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    Stop Use and Ask a Doctor if redness or irritation occurs. Avoid contact with eyes.

    When using this product, avoid contact with eyes. If contact occurs, flush thoroughly with water. If your skin will be exposed to the sun after use, apply a sunscreen with an SPF of 30 or greater.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Shake well before use.
    • Cleanse skin thoroughly before applying this product.
    • Dispense onto cotton pad and sweep over face, neck and chest. Avoid immediate eye area. Do not rinse.
  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, Glycolic Acid, Gluconolactone, Glycerin, Dimethyl Isosorbide, Sodium PCA, Sorbitan Oleate Decylglucoside Crosspolymer, Sodium Benzoate, Betaine, Akebia Quinata Extract, Hibiscus Sabdariffa Flower Extract, Fragrance, Sodium Hyaluronate, Sodium Hydroxide.

  • Questions or Comments?

    Call toll free 646-979-3997

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Naturopathica Holistic Health, Inc.
    New York, NY 10001. Dublin, Ireland. London, England.

  • PRINCIPAL DISPLAY PANEL - 150 ML Bottle Carton

    NATUROPATHICA®
    FOR DEEPER BEAUTY

    CHILL
    CHOCOLATE VINE
    DETOX TONIC

    LOTION TONIQUE
    RELAXATION

    5 FL OZ / 150 ML

    PRINCIPAL DISPLAY PANEL - 150 ML Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NATUROPATHICA CHILL CHOCOLATE VINE DETOX TONIC 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64657-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Glycolic Acid (UNII: 0WT12SX38S)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethyl Isosorbide (UNII: SA6A6V432S)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Betaine (UNII: 3SCV180C9W)  
    Hibiscus Sabdariffa Flower (UNII: 45TGG6IU6M)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64657-005-011 in 1 CARTON01/01/2022
    1150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2022
    Labeler - Naturopathica Holistic Health (104302175)
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