Label: NATUROPATHICA CHLOROPHYLL AND SALICYLIC ACID SPOT TREATMENT- salicylic acid gel

  • 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 December 1, 2021

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  • ACTIVE INGREDIENTS

    SALICYLIC ACID 2.0%

  • PURPOSE

    ACNE TREATMENT

  • Use

    for the management of acne.

    Penetrates pores to eliminate most acne blemishes.

  • Warnings

    For external use only

    When using this product

    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • Do not use if you have very sensitive skin or are sensitive to Salicylic Acid.
    • skin irritation and dryness may occur if you use another topical acne medication at the same time or immediately following. If irritation occurs, only use one topical acne medication at a time unless directed by a doctor.

    Stop use and ask a doctor

    If irritation becomes severe.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    On cleansed, completely dry skin, apply a thick, even layer directly on the blemish or blemished areas avoiding eye area, eyebrows, and hairline. Do not rub in. IN the morning or when product is dry to the touch, gently peel off starting from the outer edges of the spot. Rinse any residue with warm water.

  • Questions or comments?

    Call toll free 646.979.3997

  • INACTIVE INGREDIENTS

    WATER (AQUA), PROPANEDIOL, ALOE BARBADENSIS LEAF JUICE, ALCOHOL, ALGIN, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, MALTODEXTRIN, BIXA ORELLANA SEED EXTRACT, GLYCERIN, NYMPHAEA CAERULEA FLOWER EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, MEDICAGO SATIVA (ALFALFA) EXTRACT, HYDROLYZED PEA PROTEIN, CARAMEL, CITRUS LIMON (LEMON) PEEL OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, MENTHA VIRIDIS (SPEARMINT) LEAF OIL, SODIUM BENZOATE, POTASSIUM SORBATE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT.

    CERTIFIED ORGANIC

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton

    NATUROPATHICA®
    FOR DEEPER BEAUTY

    CHLOROPHYLL
    & SALICYLIC
    ACID

    SPOT
    TREATMENT

    GEL
    ANTI-
    IMPERFECTIONS

    0.5 FL OZ / 15 ML

    PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton
  • INGREDIENTS AND APPEARANCE
    NATUROPATHICA CHLOROPHYLL AND SALICYLIC ACID SPOT TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64657-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propanediol (UNII: 5965N8W85T)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Alcohol (UNII: 3K9958V90M)  
    Sodium Alginate (UNII: C269C4G2ZQ)  
    Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Bixa Orellana Seed (UNII: O87354RZ5A)  
    Glycerin (UNII: PDC6A3C0OX)  
    Nymphaea Caerulea Flower (UNII: S9560USZ74)  
    Nelumbo Nucifera Flower (UNII: 61W322NLDV)  
    Medicago Sativa Whole (UNII: DJO934BRBD)  
    Caramel (UNII: T9D99G2B1R)  
    Lemon Oil, Cold Pressed (UNII: I9GRO824LL)  
    Rosemary Oil (UNII: 8LGU7VM393)  
    Spearmint Oil (UNII: C3M81465G5)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Rosemary (UNII: IJ67X351P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64657-002-021 in 1 CARTON03/31/2020
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/31/2020
    Labeler - Naturopathica Holistic Health (104302175)
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