Label: NATRIA ACNE TREATMENT- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 30, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredients

    Salicylic Acid            1%

    Warning: For external use only. Avoid contact with eyes. Rinse with water if eye contact occurs. Discontinue use and contact a doctor if irritation develops and persists.

    Application: Apply a thin layer evenly over face until completely absorbed. Follow with moisturizer as needed. Use morning and evening.

    Inactive Ingredients: Water (Aqua), Butylene Glycol, Antemisia Princeps extract, algae extract, alpha-glucan oligosaccharide, Glycyrrhiza glabra (licorice) root extract, Retinyl Palmitate (Vitamine A), Panthenyl Triacetate (Vitamin B), Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Aloe Barbadensis, Camellia Oleifera (Green tea) leaf extract, Chamomilla recutita (matricaria) flower extract, Ginkgo biloba leaf extract, panax ginseng root extract, ulva lactuca (sea lettuce) extract, Vitis vinifera (grape) seed extract, ergothioneine, sclerotium gum, PEG-8 dimethicone, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben.
    image of seconday package label

  • PRINCIPAL DISPLAY PANEL

    Natria

    Acne Treatment Gel

    30 ml/ 1 fl. oz.

    image of primary label

  • INGREDIENTS AND APPEARANCE
    NATRIA  ACNE TREATMENT
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-535
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID30 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44717-535-021 in 1 BOX
    1NDC:44717-535-0130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33306/28/2010
    Labeler - Wasatch Product Development, Inc. (962452533)
    Registrant - Natures Sunshine Products (081832388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wasatch Product Development, Inc.962452533manufacture