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 April 15, 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

    Adults and children
    12 years and older
    Up to 6 times daily or after
    each bowel movement
    Children under 12Consult a doctor

    • 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.

  • OTHER INFORMATION

    • Store at room temperature: 15°- 30° C (59° - 86° F)
    • For best results, flush only one wipe at a time
  • 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, sodium citrate, water
  • QUESTIONS


  • PACKAGE INFORMATION - LABEL

    NDC 50730-7993-1
    Compare to Preparation H® active ingredient*

    CAREONE®

    pre-moistened
    MEDICATED WIPES
    HEMORRHOIDAL WIPES WITH WITCH HAZEL WITH ALOE

    Comforts, Soothes
    Cools Irritated Tissue
    Flushable

    48 WIPES


    Distributed by:
    American Sales Company
    4201 Walden Avenue
    Lancaster, NY, 14086

    ©2010 S and S Brands, Inc,
    www.Care1.info

    Quality Guaranteed or your money back.

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




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  • INGREDIENTS AND APPEARANCE
    MEDICATED WIPES 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-7993
    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:50730-7993-148 in 1 PACKAGE
    14.5 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/13/2010
    Labeler - Triad Group (050259597)