Label: HYGIENIC CLEANSING 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 4, 2010

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  • ACTIVE INGREDIENT

    Witch Hazel 50% v/v

  • PURPOSE

    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.

    Sunmark®

    COMPARE TO TUCKS® ACTIVE INGREDIENTS*
    NDC 49348-459-10

    hygienic cleansing pads
    Pre-Moistened


    Cools, soothes and helps relieve local discomfort associated with hemorrhoids

    Witch Hazel, 50%

    HEMORRHOIDAL / VAGINAL PADS

    100 PADS

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


    Distributed by McKesson
    One Post Street, San Francisco, CA 94104
    Money Back Guarantee
    label
  • PACKAGE INFORMATION - 100 COUNT CARTON This package is a representation. Packaging is similar for other sizes available.

    Sunmark®

    COMPARE TO TUCKS® ACTIVE INGREDIENTS*
    NDC 49348-459-10

    hygienic cleansing pads
    Pre-Moistened

    Cools, soothes and helps relieve local discomfort associated with hemorrhoids

    Witch Hazel, 50%

    HEMORRHOIDAL / VAGINAL PADS

    100 PADS


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


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

    Another Quality Product
    Distributed by McKesson
    One Post Street
    San Francisco, CA 94104
    Money Back Guarantee

    Please visit us at www.sunmarkbrand.com



    carton

  • INGREDIENTS AND APPEARANCE
    HYGIENIC CLEANSING PADS 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-459
    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:49348-459-10100 in 1 JAR
    12.5 mL in 1 APPLICATOR
    2NDC:49348-459-5940 in 1 JAR
    22.5 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/18/2003
    Labeler - McKesson (177667227)
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