Label: RELIEF TOWELETTE- 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 December 2, 2009

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  • Active ingredient

    Witch Hazel 50%

  • Purpose

    Astringent

  • Use

    For temporary relief of local discomfort, burning, and irritation associated with hemorrhoids.
  • Warnings

    For external use only.
    Avoid contact with eyes.

    Do not

    put this product into the rectum using fingers or any mechanical device or applicator.




    Stop use and ask a doctor

    • if condition worsens or does not improve within 7 days
    • in case of bleeding
    • before exceeding the recommended dosage.



    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.
  • SPL UNCLASSIFIED SECTION


  • Other information

    Store at room temperature 15° -30° C (59° - 86° F)
  • Inactive Ingredients

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


  • Package Information

    Cat. No. 10-5400
    NDC 50730-5400-0


    Relief
    Medicated hemorrhoidal towelettes
    Comfort, soothe, cool - pH balanced

    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029 USA

    Made in USA
    www.triad-group.net

    100 Towelettes

    carton
  • INGREDIENTS AND APPEARANCE
    RELIEF TOWELETTE 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-5400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34) witch hazel.5 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:50730-5400-0100 in 1 CARTON
    11 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/17/1994
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture
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