Label: ZIRO- hamamelis virginiana top water cream

  • NDC Code(s): 83313-0001-3
  • Packager: ZENMED Raging Creations Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Witch Hazel Distillate(35%)

  • Purpose

    Temporary Pain Reliever

  • Uses

    For the temporary relief of anorectal discomfort associated with hemorrhoids.

  • Warnings

    FOR EXTERNAL USE ONLY. If your condition does not improve after 7 days or bleeding occurs, consult a doctor. Do not exceed the recommended daily dosage unless directed by a doctor. Do not insert this product into the rectum using fingers or applicator. If pregnant or breast-feeding, consult a health professional before use. Children under 12 years of age, consult a doctor before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • Directions

    Apply externally to the affected area up to 6 times daily or after each bowel movement. Wash hands thoroughly before and after use.

  • Inactive Ingredients

    Purified Water, Extracts of Sage, Coltsfoot, Yarrow, Balm Mint, Chamomile, Rosemary, Althea, Wild Thyme, & Horsetail. Vegetable Glycerin, Certified Organic Sunflower Oil & Aloe Vera Gel, Vitamins A, D3 & E, Soy Lecithin, Cocoa Butter, Stearic Acid, Octyl Palmitate, Allantoin, Benzyl Alcohol, Phenoxyethanol, Ethyl Hexyl Glycerin. 100% Vegan Ingredients.

  • PRINCIPAL DISPLAY PANEL - 60 ml Tube Label

    ZIRO
    Herbal Cream for
    the Rapid Relief
    of Hemorrhoids

    + Witch Hazel to Shrink &
    Calm Inflamed Tissues

    + Based in All-Natural Cocoa
    Butter to Soothe and Protect

    + Made with Certified
    Organic Sunflower Oil &
    Aloe Vera Gel

    60 ml | 2 fl. oz
    Made In The USA

    RINCIPAL DISPLAY PANEL - 60 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    ZIRO 
    hamamelis virginiana top water cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83313-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) (HAMAMELIS VIRGINIANA TOP WATER - UNII:NT00Y05A2V) HAMAMELIS VIRGINIANA TOP WATER350 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SAGE (UNII: 065C5D077J)  
    TUSSILAGO FARFARA (UNII: 0JXZ63016V)  
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ROSEMARY (UNII: IJ67X351P9)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    WILD THYME (UNII: KXK6I80R8W)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VITAMIN A (UNII: 81G40H8B0T)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    OCTYL PALMITATE (UNII: UYY8LE6Q5Y)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83313-0001-360 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01511/01/2023
    Labeler - ZENMED Raging Creations Ltd. (203762150)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc.189788201MANUFACTURE(83313-0001)
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