Label: MEDICATED PADS- witch hazel solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 February 1, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Witch Hazel 50% v/v

  • PURPOSE

    Hemorrhoidal Astringent

  • USE

    For temporary relief of local discomfort, burning, and irritation associated with hemorrhoids
  • WARNINGS

    For external use only. Avoid contact with eyes.

    Consult a doctor

    • if condition worsens or does not improve within 7 days
    • in case of bleeding
    • before exceeding the recommended dosage

    Do not

    put this product into rectum using fingers or any mechanical device or applicator






    Keep out of reach of children

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

  • DIRECTIONS

    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
    • Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. Gently apply to the affected area by patting and then discard. Apply to the affected area up to 6 times daily or after each bowel movement.
    • Children under 12 years of age: consult a doctor.
  • OTHER INFORMATION

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

  • SPL UNCLASSIFIED SECTION


    Hygienic wipe
    • Effective for everyday personal hygienic use on outer rectal and vaginal areas.
    • Cleanse the area by gently wiping, patting or blotting with pad to gently and thoroughly remove irritation-causing matter. Discard and repeat as needed.
    Vaginal care
    • Freshens and cleanses the area, especially during menstrual periods.
    • Gently wipe, pat or blot with pad and discard. Repeat as needed.
    Moist compress
    • Relieves discomfort following childbirth, rectal or vaginal surgery.
    • If necessary, first cleanse the area as previously described.
    • Fold pad and place in contact with inflamed tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.
  • INACTIVE INGREDIENTS

    citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate
  • QUESTIONS?

    Call 1-800-910-6874

  • PACKAGE INFORMATION - JAR

    NDC 11673-675-12

    UP AND UP

    medicated hemorrhoidal pads

    witch hazel

    Compare to Tucks®*

    helps cool and soothe
    pH balanced for hemorrhoidal and vaginal care

    100 PADS

    OTHER USES

    For vaginal care - cleanse the affected area by gently wiping, patting or blotting with pad and discard. Repeat as needed.


    FOR YOUR PROTECTION, JAR IS SEALED. REMOVE LID. IF IMPRINTED SEAL IS BROKEN OR MISSING, DO NOT USE.

    Distributed by Target Corporation
    Minneapolis, MN 55403
    Made in U.S.A.

    ©Target Brands, Inc.

    All rights reserved

    Shop Target.com

    *This product is not manufactured or distributed by McNeill-PPC, Inc., owner of the registered trademark Tucks®.



    label



  • PACKAGE INFORMATION - CARTON

    NDC 11673-675-12
    UP AND UP

    medicated hemorrhoidal pads
    witch hazel

    Compare to Tucks®*

    helps cool and soothe
    pH balanced
    for hemorrhoidal and vaginal care

    100 PADS


    Distributed by Target Corporation
    Minneapolis, MN 55403
    Made in U.S.A.

    ©Target Brands, Inc.

    All rights reserved
    Shop Target.com

    *This product is not manufactured or distributed by McNeill-PPC, Inc., owner of the registered trademark Tucks®.


    FOR YOUR PROTECTION, JAR IS SEALED. REMOVE LID. IF IMPRINTED SEAL IS BROKEN OR MISSING, DO NOT USE.



    carton

  • INGREDIENTS AND APPEARANCE
    MEDICATED PADS 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-675
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34) witch hazel0.50 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    diazolidinylurea (UNII: H5RIZ3MPW4)  
    glycerin (UNII: PDC6A3C0OX)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-675-12100 in 1 JAR
    12.5 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/01/2007
    Labeler - Target Corporation (006961700)