Label: THE PHARMA-C COMPANY MEDICATED HEMORRHOIDAL PADS- witch hazel cloth

  • NDC Code(s): 55239-359-00
  • Packager: Kleen Test Products Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 9, 2023

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  • Drug Facts

  • Active ingredient

    Witch hazel (50% w/w)

    Purpose

    Hemorrhoidal astringent

  • Uses

    • temporarily relieves the local itching and discomfort associated with hemorrhoids
    • aids in protecting irritated anorectal areas
    • temporarily relieves irritation anc burning
  • Warnings

    For external use only.

    When using this product 

    • do not use more than directed unless told to do so by a doctor 
    • do not put directly in the rectum or vagina by using fingers or mechanical device 

    Stop use and ask doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults:   
    • when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply externally to the affected area up to 6 times daily or after each bowel movement
    • after application, discard pad and wash hands

    Children under 12 years of age: ask a doctor

  • Other information

    Store at a controlled room temperature: 15-30°C (59-86°F)

  • Inactive ingredients

    aloe barbadensis leaf juice, benzyl alcohol, citric acid, coco-glucoside, ethyl alcohol, glycerin, phenoxyethanol, potassium sorbate, propanediol, purified water, sodium citrate, tocopherol

  • Questions or comments?

    1-844-308-8600

  • Package Labeling:

    Label01

  • INGREDIENTS AND APPEARANCE
    THE PHARMA-C COMPANY MEDICATED HEMORRHOIDAL PADS 
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55239-359
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55239-359-00100 in 1 JAR05/01/2021
    12 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01505/01/2021
    Labeler - Kleen Test Products Corporation (168165814)
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