Label: RELIEF- witch hazel swab

  • 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 November 23, 2009

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  • ACTIVE INGREDIENT

    Witch Hazel 50%

  • PURPOSE

    Astringent

  • USES

    Temporarily relieves these symptoms associated with hemorrhoids:
    • itching
    • burning
    • irritation
  • WARNINGS

    For external use only.

    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

    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.
  • SPL UNCLASSIFIED SECTION


  • STORAGE AND HANDLING


  • Inactive ingredients

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


  • Package Information

    CAT. NO. 10-7540

    NDC 50730-7502-1


    Relief
    Pre-Moistened
    Hemorrhoidal Pads
    Comforts - Cools - Soothes

    Compares to the leading brand

    40 PADS


    Triad Disposables, Inc.
    Brookfield, WI 53045
    Made In USA

    label

  • INGREDIENTS AND APPEARANCE
    RELIEF 
    witch hazel swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-7502
    Route of AdministrationRECTAL, TOPICAL
    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:50730-7502-140 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/14/1997
    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. / Triad Group050259597manufacture
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