Label: PRE-MOISTENED HEMORRHOIDAL PADS- witch hazel solution

  • 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 February 2, 2010

If you are a healthcare professional or from the pharmaceutical industry 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)

  • OTHER USES

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

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


  • PACKAGE INFORMATION - 100 COUNT JAR This package is a representation. Packaging is similar for other sizes available.

    For your protection, jar is sealed. Remove lid. If seal is broken or missing, do not use.

    Equaline

    Compare to Tucks® active ingredients*

    NDC 41163-263-51

    pre-moistened
    hemorrhoidal pads
    with witch hazel

    100 medicated pads


    Distributed by
    Albertsons, Inc.
    Boise, Idaho 83726


    *This product is not manufactured or distributed by Parke-Davis, Div. of Warner Lambert Co., owner of the registered trademark TUCKS®.

    We're committed to your satisfaction and guarantee the quality of this product. Contact us at 1/877-932-7948, or www.albertsons.com




    label



  • PACKAGE INFORMATION - 100 COUNT CARTON This package is a representation. Packaging is similar for other sizes available.

    For your protection, jar is sealed. Remove lid. If seal is broken or missing, do not use.

    Compare to Tucks® active ingredients*

    NDC 41163-263-51

    pre-moistened
    hemorrhoidal pads
    with witch hazel

    comforts - soothes - cools

    uses:

        * to soothe, cool, and comfort itching, burning, and irritation of sensitive rectal areas.
        * an effective hygiene wipe to cleanse rectal area of irritation causing residue
        * provides a fresh and clean feeling
        * solution is pH balanced

    100 medicated pads

    Distributed by
    Albertsons, Inc.
    Boise, Idaho 83726


    *This product is not manufactured or distributed by Parke-Davis, Div. of Warner Lambert Co., owner of the registered trademark TUCKS®.

    We're committed to your satisfaction and guarantee the quality of this product. Contact us at 1/877-932-7948, or www.albertsons.com

    carton


  • INGREDIENTS AND APPEARANCE
    PRE-MOISTENED HEMORRHOIDAL PADS 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-263
    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:41163-263-5040 in 1 JAR
    12.5 mL in 1 APPLICATOR
    2NDC:41163-263-51100 in 1 JAR
    22.5 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/01/2004
    Labeler - Supervalu Inc (006961411)