Label: THERA WISE NATURAL ACNE- salicylic acid ointment

  • NDC Code(s): 43347-189-01
  • Packager: Derma Wise Skin Care Ltd.
  • 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 January 19, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 0.5%

  • Purpose

    Astringent/Anti-inflammatory

  • Use

    Helps treat acne pimples and allows skin to heal

  • Warnings

    For external use only.

    When using this product

    • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • 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 a day or every other day.

    Keep out of reach of children

  • Directions

    • See warnings under "When using this product".
    • Cleanse skin thoroughly before applying the product.
    • Apply product to affected areas one to three times daily or as directed by a health care practitioner.
  • Other information

    Store at 2°- 25° C (35°- 77° F)

  • Inactive ingredients

    Aloe Leaf Extract1, Alpha Glucan Oligosaccharide, Alpha Lipoic Acid, Cetearyl Olivate, Dehydroacetic Acid, Denatured Alcohol, Marine Algae Extract, Oat Beta-Glucan, Olive Squalane Peppermint Oil1, Rose Hip Seed Oil1, Sclerotium Gum, Sodium Anisate, Sodium Levulinate, Sorbitan Olivate, Tamanu Oil1, Tapioca Starch1, Tea Tree Oil, Tocopherols, Water, Witch Hazel Extract.


    1
    Certified Organic
  • Questions or Comments?

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  • PRINCIPAL DISPLAY PANEL - 28 g Tube Box

    THÉRA WISE®

    Natural Acne Treatment
    SALICYLIC ACID, 0.5 %
    Clears acne blemishes without over drying
    Prevents new acne from forming

    WITH TAMANU OIL, OAT PREBIOTICS, ALOE VERA
    LEAF EXTRACT, ROSEHIP SEED OIL, WILLOW
    & WITCH HAZEL BARK EXTRACTS

    NET WT 1OZ (28g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Box
  • INGREDIENTS AND APPEARANCE
    THERA WISE NATURAL ACNE 
    salicylic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43347-189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.14 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    .Alpha.-Glucan Oligosaccharide (UNII: S95658MI3W)  
    ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)  
    Alcohol (UNII: 3K9958V90M)  
    Squalane (UNII: GW89575KF9)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Rosa Moschata Oil (UNII: J99W255AWF)  
    Betasizofiran (UNII: 2X51AD1X3T)  
    Sodium Anisate (UNII: F9WFJ28MV9)  
    Sodium Levulinate (UNII: VK44E1MQU8)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Tamanu Oil (UNII: JT3LVK84A1)  
    Starch, Tapioca (UNII: 24SC3U704I)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Tocopherol (UNII: R0ZB2556P8)  
    Water (UNII: 059QF0KO0R)  
    Hamamelis Virginiana Top (UNII: UDA30A2JJY)  
    Nori (UNII: 477TV3P5UX)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43347-189-011 in 1 BOX08/15/2016
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D08/15/2016
    Labeler - Derma Wise Skin Care Ltd. (242166531)