Label: GNP MEDICATED WIPES - witch hazel solution 

  • 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 06/13

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

    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: 15° - 30 °C (59° - 86°F)

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  • INACTIVE INGREDIENT

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

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  • DOSAGE & ADMINISTRATION

    Distributed By

    Amerisource Bergen

    1300 Morris Drive

    Chesterbrook, PA 19067


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  • INGREDIENTS AND APPEARANCE
    GNP MEDICATED WIPES 
    witch hazel solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46122-055
    Route of Administration TOPICAL, RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 0.5 mg  in 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    DIAZOLIDINYL UREA  
    GLYCERIN  
    METHYLPARABEN  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    SODIUM CITRATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46122-055-67 48 in 1 POUCH
    1 0.5 mg in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 06/30/2013
    Labeler - Amerisource Bergen (007914906)
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