Label: GNP HYGIENIC CLEANSING PADS - 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%......................................................Astringent

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  • PURPOSE

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

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  • WARNINGS

    Warnings For external use only. Avoid contacts with eyes.

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  • 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
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  • STOP USE

    Stop use and ask a doctor if

    • Rectal bleeding occurs
    • Condition worsens or does not improve within 7 days
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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

    • 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
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  • STORAGE AND HANDLING

    Other information: store at 20° to 25°C (68° to 77°F)

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  • INACTIVE INGREDIENT

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

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  • DOSAGE & ADMINISTRATION

    Distributed By:

    Amerisource Bergen

    1300 Morris Drive

    Chesterbrook, PA 19087

    Made in China

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  • INGREDIENTS AND APPEARANCE
    GNP HYGIENIC CLEANSING PADS 
    witch hazel solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46122-054
    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
    ALCOHOL  
    CITRIC ACID MONOHYDRATE  
    METHYLPARABEN  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    SODIUM CITRATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46122-054-78 100 in 1 JAR
    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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