Label: HYGIENIC CLEANSING PAD- 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 December 7, 2009

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  • ACTIVE INGREDIENT

    Witch Hazel 50% v/v

  • PURPOSE

    Hemorrhoidal Astringent

  • USES

    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

    • As a hemorrhoidal treatment for adults and children 12 years of age and older
    • 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


  • LABEL INFORMATION

    DISCOUNT
    DRUG MART
    FOOD FAIR

    NDC 50730-7503-1

    Compare to the active ingredient in TUCKS®.

    Hygienic
    Cleansing
    MEDICATED PADS

    • Pre-moistened
    • Use for Hemorrhoidal or Vaginal Care
    100 PADS

    Do not use if printed seal under cap is torn or missing

    DISTRIBUTED BY DRUG MART FOOD FAIR
    MEDINA, OHIO 44256

    This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owver of the registered trademark Preparation H®.

    label

  • INGREDIENTS AND APPEARANCE
    HYGIENIC CLEANSING PAD 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-7503
    Route of AdministrationRECTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34) witch hazel.5 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:50730-7503-1100 in 1 JAR
    12.5 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/01/2008
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
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