Label: THERA WISE NATURAL ACNE- salicylic acid ointment

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 19, 2022

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  • 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)
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