Label: NATUROPATHICA COLLOIDAL SILVER AND SALICYLIC ACID ACNE CLEARING CLEANSER- 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

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • 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

    Take a quarter sized amount of the product in wet hands and work into a fine lather. Apply to dry face and massage for 60 seconds. Rinse with warm water and pat the skin dry. Use twice daily.

  • STORAGE AND HANDLING

    Keep out of direct sunlight after use. Use a sunscreen.

  • INACTIVE INGREDIENTS

    WATER(AQUA), DECYL GLUCOSIDE, GLYCERIN, ALOE BARBADENSIS LEAF JUICE, XANTHAN GUM, COLLOIDAL SILVER, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, SODIUM HYDROXIDE, SODIUM COCOYL HYDROLYZED AMARANTH PROTEIN, SODIUM BENZOATE, POTASSIUM SORBATE, CITRUS LIMON (LEMON) PEEL OIL , ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, MENTHA VIRIDIS(SPEARMINT) LEAF OIL, PROPANEDIOL, NYMPHAEA CAERULEA FLOWER EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT.

    CERTIFIED ORGANIC

  • Questions or Comments?

    call toll free 646-979-3997

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton

    NATUROPATHICA®
    FOR DEEPER BEAUTY

    COLLOIDAL
    SILVER &
    SALICYCLIC ACID

    ACNE CLEARING
    CLEANSER

    5 FL OZ / 150 ML

    PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NATUROPATHICA COLLOIDAL SILVER AND SALICYLIC ACID ACNE CLEARING CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64657-001
    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)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SILVER (UNII: 3M4G523W1G)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    NYMPHAEA CAERULEA FLOWER (UNII: S9560USZ74)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    ROSEMARY (UNII: IJ67X351P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64657-001-011 in 1 CARTON03/31/2020
    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 finalpart333D03/31/2020
    Labeler - Naturopathica Holistic Health (104302175)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!