TUCKS MULTI-CARE RELIEF KIT (TUCKS HEMORRHOIDAL AND TUCKS MEDICATED COOLING 40 COUNT) (GLYCERIN, LIDOCAINE, AND WITCH HAZEL) KIT [BLISTEX INC]

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  • TUCKS MULTI-CARE RELIEF KIT (TUCKS HEMORRHOIDAL AND TUCKS MEDICATED COOLING 40 COUNT) (GLYCERIN, LIDOCAINE, AND WITCH HAZEL) KIT [BLISTEX INC]

TUCKS MULTI-CARE RELIEF KIT (TUCKS HEMORRHOIDAL AND TUCKS MEDICATED COOLING 40 COUNT) (GLYCERIN, LIDOCAINE, AND WITCH HAZEL) KIT [BLISTEX INC]
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NDC 10157-2112-1
Set ID a7cb6d78-3048-43b3-afe7-4d862fdcfd3f
Category HUMAN OTC DRUG LABEL
Packager Blistex Inc
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
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  • SPL UNCLASSIFIED SECTION

    Tucks® Hemorrhoidal Cream

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Glycerin 15.0% (w/w)Protectant
    Lidocaine 5.0% (w/w)Local anesthetic
  • Uses

    • temporarily relieves the local pain, itching and discomfort associated with hemorrhoids
    • temporarily provides a coating for relief of anorectal discomforts
    • temporarily relieves rectal irritation and burning
  • Warnings

    For external use only

    When using this product

    • do not exceed the recommended daily dosage unless directed 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
    • certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

    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

    Children under 12 years of age: ask a doctor

  • Inactive ingredients

    arachidyl alcohol, arachidyl glucoside, avena sativa kernel flour (colloidal oatmeal), behenyl alcohol, disodium EDTA, ethylhexylglycerin, microcrystalline wax, petrolatum, phenoxyethanol, polyglyceryl-3 diisostearate, polysorbate 60, purified water, sorbitan isostearate, stearyl behenate

  • SPL UNCLASSIFIED SECTION

    Tucks® Medicated Cooling Pads

    Drug Facts

  • Active ingredient

    Witch hazel (50% v/v)

  • 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, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    TUCKS®

    New

    MULTI-CARE
    RELIEF KIT

    Cream: Local Anesthetic / Protectant
    Pads: Astringent

    Lidocaine 5% Cream
    to numb & protect
    painful hemorrhoids
    +
    Witch Hazel Pads
    to cleanse & soothe
    rectal or vaginal areas

    TUCKS®
    HEMORRHOIDAL CREAM
    MAXIMUM STRENGTH LIDOCAINE

    with
    Colloidal
    Oatmeal

    TUCKS®
    MEDICATED COOLING PADS
    WITH WITCH HAZEL
    40 PADS

    with
    Ultra-soft
    Fabric

    Net Wt. 0.5 oz.
    (14 g) - 1 Tube

    2-Product Value

    40 Pads
    1 Jar

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    TUCKS MULTI-CARE RELIEF KIT (TUCKS HEMORRHOIDAL AND TUCKS MEDICATED COOLING 40 COUNT) 
    glycerin, lidocaine, and witch hazel kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-2112
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-2112-11 in 1 CARTON02/15/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 14 g
    Part 21 APPLICATOR 1 mL
    Part 1 of 2
    TUCKS HEMORRHOIDAL 
    glycerin, and lidocaine cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN15 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARYL BEHENATE (UNII: A68S9UI39D)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    OATMEAL (UNII: 8PI54V663Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34602/15/2019
    Part 2 of 2
    TUCKS MEDICATED COOLING 
    witch hazel solution
    Product Information
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34602/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34602/15/2019
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-2112)
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