Label: TUCKS MEDICATED COOLING PADS- witch hazel solution

  • NDC Code(s): 10157-2103-1, 10157-2103-2, 10157-2103-3, 10157-2103-4
  • Packager: Blistex Inc
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 15, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Witch hazel (50% w/w)

  • Purpose

    Astringent

  • Uses

    • temporarily relieves the local itching and discomfort associated with hemorrhoids
    • aids in protecting irritated anorectal areas
    • temporarily relieves irritation and 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 by using fingers or any mechanical device or applicator

    Stop use and ask a 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

    • for use as a moist compress — if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but not to exceed directions for use
  • Inactive ingredients

    citric acid, disodium EDTA, ethylhexylglycerin, glycerin, phenoxyethanol, potassium sorbate, purified water, sodium citrate

  • PRINCIPAL DISPLAY PANEL - 100 Pad Jar Carton

    TUCKS®

    MEDICATED COOLING PADS

    HEMORRHOIDAL PADS WITH WITCH HAZEL

    immediate relief from burning
    and itching caused by hemorrhoids

    witch hazel soothes and
    protects irritated areas

    BRAND USED BY HOSPITALS®

    100 PADS

    PRINCIPAL DISPLAY PANEL - 100 Pad Jar Carton
  • INGREDIENTS AND APPEARANCE
    TUCKS MEDICATED COOLING PADS 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-2103
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-2103-21 in 1 CARTON08/30/2016
    1100 in 1 JAR
    11 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:10157-2103-11 in 1 CARTON08/30/2016
    240 in 1 JAR
    21 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:10157-2103-340 in 1 JAR08/30/2016
    31 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    4NDC:10157-2103-42 in 1 CARTON08/30/2016
    4100 in 1 JAR
    41 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/30/2016
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354manufacture(10157-2103)
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