Label: LEADER MEDICATED WIPE- 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% v/v................................................................Astringent

  • PURPOSE

    Uses

    For temporary relief of local discomfort itching, burning, and irritation associated with hemorrhoids

  • WARNINGS

    For external use only.  Avoid contact with eyes.

  • ASK DOCTOR

    Consult a doctor

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

    Do not put this product into rectum using fingers or any mechanical device or applicator

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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

    Adults and children 12 years and older, up to 6 times daily or after each bowel movement

    Children under 12, consult 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 discard

    Apply to the affected area up to 6 times daily or after each bowel movement

  • STORAGE AND HANDLING

    Other information

    Store at room temperature: 15o-30oC (59o-86oF)

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CIN 4246294

    www.myleader.com

    1-800-200-6313

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    LEADER MEDICATED WIPE  
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-741
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL5 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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:37205-741-6748 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/01/2012
    Labeler - CARDINAL HEALTH (097537435)
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