Label: GNP MEDICATED WIPES- witch hazel solution

  • Category: HUMAN OTC DRUG LABEL

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 June 30, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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

    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: 15° - 30 °C (59° - 86°F)

  • INACTIVE INGREDIENT

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

  • DOSAGE & ADMINISTRATION

    Distributed By

    Amerisource Bergen

    1300 Morris Drive

    Chesterbrook, PA 19067


  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    GNP MEDICATED WIPES 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-055
    Route of AdministrationTOPICAL, RECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-055-6748 in 1 POUCH
    10.5 mg in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/30/2013
    Labeler - Amerisource Bergen (007914906)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!