Label: LEADER MEDICATED WIPE  - witch hazel solution 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                                                       Purpose

    Witch Hazel, 50% v/v................................................................Astringent

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  • PURPOSE

    Uses

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

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  • WARNINGS

    For external use only.  Avoid contact with eyes.

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  • ASK DOCTOR

    Consult a doctor

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

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

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  • PREGNANCY OR BREAST FEEDING

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

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  • 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.

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  • 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

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  • STORAGE AND HANDLING

    Other information

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

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  • INACTIVE INGREDIENT

    Inactive ingredients

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

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  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CIN 4246294

    www.myleader.com

    1-800-200-6313

    Made in China

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  • INGREDIENTS AND APPEARANCE
    LEADER MEDICATED WIPE  
    witch hazel solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-741
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 5 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    CITRIC ACID MONOHYDRATE  
    DIAZOLIDINYL UREA  
    GLYCERIN  
    METHYLPARABEN  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    SODIUM CITRATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-741-67 48 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 03/01/2012
    Labeler - CARDINAL HEALTH (097537435)
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