Label: MEDICATED WIPES- 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 12, 2010

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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.
    • for use as a moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.
  • INACTIVE INGREDIENTS

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


  • PACKAGE INFORMATION - PEEL AWAY LABEL

    Sunmark TM

    COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*
    NDC 49348-559-08

    pre-moistened
    medicated wipes

    for hemorrhoidal and vaginal care

    Witch Hazel, 50%

    FOUR TIMES LARGER THAN MEDICATED PADS

    48 FLUSHABLE MEDICATED WIPES
    5.6 X 6.0 IN (14.3 X 15.2 cm)

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

    *This product is not manufactured or distributed by Whitehail-Robins Healthcare, owner of the registered trademark PREPARATION H®.

    Peel and  Reseal
    LIFT HERE

    Tear off and discard strip to begin use
    Rev. A



    label



  • PACKAGE INFORMATION - SLEEVE

    Sunmark TM

    COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*

    NDC 49348-559-08

    pre-moistened
    medicated wipes


    For hemorrhoidal and vaginal care

    Contains Aloe
    Witch Hazel, 50%

    FOUR TIMES LARGER THAN MEDICATED PADS

    48 FLUSHABLE MEDICATED WIPES
    5.6 X 6.0 IN (14.3 X 15.2 cm)


    *This product is not manufactured or distributed by Whitehail-Robins Healthcare, owner of the registered trademark PREPARATION H®.

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

    Money Back Guarantee
    Please visit us
    at www.sunmarkbrand.com


    sleeve

  • INGREDIENTS AND APPEARANCE
    MEDICATED WIPES 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-559
    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
    aloe vera leaf (UNII: ZY81Z83H0X)  
    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:49348-559-0848 in 1 PACKAGE
    14.5 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/19/2003
    Labeler - McKesson (177667227)