TUCKS MEDICATED COOLING PADS (WITCH HAZEL) SOLUTION [BLISTEX INC]

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TUCKS MEDICATED COOLING PADS (WITCH HAZEL) SOLUTION [BLISTEX INC]
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NDC 10157-2103-1, 10157-2103-2, 10157-2103-3
Set ID b3e68008-3d0d-4124-9579-b503e9fb95c9
Category HUMAN OTC DRUG LABEL
Packager Blistex Inc
Generic Name
Product Class
Product Number
Application Number PART346
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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
    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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