Label: THERA WISE NATURAL HEMORRHOIDAL- witch hazel ointment

  • NDC Code(s): 43347-158-01
  • Packager: Derma Wise Skin Care Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Witch Hazel 12%

  • Purpose

    Astringent / Anti-inflammatory

  • Uses

    • For the temporary relief of anorectal discomfort associated with hemorrhoids
    • For the temporary relief of local itching associated with hemorrhoids
  • Warnings

    For rectal and external use only

    Allergy alert: contains Asteracea (daisy) plant material

    Do not use this product with the applicator if the introduction of the applicator into the rectum causes additional pain.

    Consult a doctor promptly.

    Stop use and consult a doctor if:

    • Condition worsens or does not improve within 7 days
    • Bleeding occurs

    When using this product do not exceed the recommended daily dosage unless directed by your doctor.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • When first opening, tear away safety seal.
    • Adult: When practical cleanse the affected area with mild soap and warm water and rinse thoroughly and / or
    • pat and blot with appropriate cleansing pad.
    • Gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product.
    • FOR INTRARECTAL USE: Remove cover from applicator, attach applicator to the tube.
    • Lubricate applicator well, then gently insert applicator into the rectum.
    • Thoroughly cleanse applicator after each use and replace cover.
    • Apply to the affected area up to 6 times daily or after each bowel movement.
    • Children under 12 years of age: consult a doctor.
  • Other information

    • Store between 2° and 25° C (35° - 77° F)
    • Do not use if seal is broken
  • Inactive ingredients

    Aloe Vera Extract1, Argan Kernel Oil, Butcher's Broom Extract, Cetearyl Olivate, Chamomile Flower Extract1, Citric Acid, Dehydroacetic Acid, Glycerin, Grape Seed Oil, Hydrogenated Olive Oil, Oat Beta Glucan, Olive Oil, Olive Oil Unsaponifiables Olive Squalane, Seabuckthorn Fruit Oil, Sclerotium Gum, Shea Butter, Sodium Anisate, Sodium Levulinate, Sorbitan Olivate, Sodium Steroyl Glutamate, Stearyl Alcohol, Sunflower Seed Oil, Tocopherols, Water


    1
    Certified Organic
  • Questions or Comments?

    Call weekdays 9am to 5pm PST @ 1.888.488.1808

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Box

    Natural Hemorrhoidal Ointment

    12 % WITCH HAZEL
    For the temporary relief of itching and
    discomfort associated with hemorrhoids

    THÉRA WISE®

    WITH BUTCHER'S BROOM, WITCH HAZEL, CHAMOMILE
    & ALOE LEAF EXTRACT, OAT PREBIOTIC,
    GRAPE SEED, SEABUCKTHORN & ARGAN OIL

    NEW WT 1OZ (28g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Box
  • INGREDIENTS AND APPEARANCE
    THERA WISE NATURAL HEMORRHOIDAL 
    witch hazel ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43347-158
    Route of AdministrationTOPICAL, RECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34) Witch Hazel3.36 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Ruscus Aculeatus Root (UNII: ZW12V95I1Q)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Chamaemelum Nobile Flower (UNII: O2T154T6OG)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Dehydroacetic acid (UNII: 2KAG279R6R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Grape Seed Oil (UNII: 930MLC8XGG)  
    Hydrogenated Olive Oil (UNII: 53839415GI)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Olea Europaea (Olive) Oil Unsaponifiables (UNII: XO45V955LT)  
    Squalane (UNII: GW89575KF9)  
    Betasizofiran (UNII: 2X51AD1X3T)  
    Shea Butter (UNII: K49155WL9Y)  
    Sodium Anisate (UNII: F9WFJ28MV9)  
    Sodium Levulinate (UNII: VK44E1MQU8)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Tocopherol (UNII: R0ZB2556P8)  
    Glucosyl Hesperidin (UNII: 432C95B6YE)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43347-158-011 in 1 BOX08/15/2016
    128 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01608/15/2016
    Labeler - Derma Wise Skin Care Ltd. (242166531)