Label: THE PHARMA C COMPANY TRIPLE ACTION HEMORRHOIDAL PADS- witch hazel, lidocaine, phenylephrine hydrochloride cloth

  • NDC Code(s): 55239-459-00
  • Packager: Kleen Test Products Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 8, 2024

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  • Drug Facts

  • Active ingredients

    Witch hazel (50% w/w)

    Lidocaine (5%)

    Phenylephrine HCl (0.25%)

    Purpose

    Hemorrhoidal astringent

    Local anesthetic

    Vasoconstrictor

  • Uses

    • temporarily relives the local itching and discomfort associated with hemorrhoids
    • temporarily relieves pain, irritation and burning
    • temporarily shrinks hemorrhoidal tissue
    • aids in protecting irritated anorectal areas
  • Warnings

    For external use only.

    Ask a doctor before use if you have

    • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor before use if you are

    presently taking a prescription drug for high blood pressure or depression

    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 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 4 times daily
    • 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

    purified water, aloe barbadensis leaf juice, glycerin, propanediol, citric acid, phenoxyethanol, benzyl alcohol, potassium sorbate, tocopherol

  • Questions or comments?

    1-844-308-8600

  • Package Labeling:

    Label1

  • INGREDIENTS AND APPEARANCE
    THE PHARMA C COMPANY TRIPLE ACTION HEMORRHOIDAL PADS 
    witch hazel, lidocaine, phenylephrine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55239-459
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55239-459-00100 in 1 JAR01/15/2024
    12 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/15/2024
    Labeler - Kleen Test Products Corporation (168165814)
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