Label: TOPCARE MEDICATED CLEANSING PADS- 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 March 1, 2012

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  • ACTIVE INGREDIENT

    Active ingredient                                                                 Purpose

    Witch Hazel 50% ...............................................................Astringent

  • PURPOSE

    Uses

    Temporarily relieves these external symptoms associated with hemorrhoids: itching, burning, and irritation

  • WARNINGS

    Warnings

    For external use only.  Avoid contact with eyes.

  • WHEN USING

    When using this product

    • Do not exceed the recommended daily dosage unless directed by a doctor
    • Do not put directly in rectum by using fingers or any mechanical device
  • STOP USE

    Stop use and ask a doctor if

    • Rectal bleeding occurs
    • Condition worsens or does not improve within 7 days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • As hemorrhoidal treatment for adults:
    • When practical clean 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 applying
    • Gently apply to the affected area by patting and then discard
    • Can be used up to six times daily or after each bowel movement
    • Children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    Store at 20o to 25oC (68o to 77oF)

  • INACTIVE INGREDIENT

    Inactive ingredients: alcohol, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY TOPCO ASSOCIATES

    7711 GROSS POINT ROAD, SKOKIE, IL 60077

    QUESTIONS? 1-888-423-0139

    topcare@topco.com

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    TOPCARE MEDICATED CLEANSING PADS 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (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:36800-068-10100 in 1 JAR
    12.5 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/01/2012
    Labeler - TOPCO ASSOCIATES LLC (006935977)
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