Your browser does not support JavaScript! GNP MEDICATED WIPES (WITCH HAZEL) SOLUTION [AMERISOURCE BERGEN]
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GNP MEDICATED WIPES (witch hazel) solution
[Amerisource Bergen]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active ingredient                                                              Purpose

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

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

Warnings For external use only. Avoid contact with eyes.

Consult a doctor

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

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other information Store at room temperature: 15° - 30 °C (59° - 86°F)

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

Distributed By

Amerisource Bergen

1300 Morris Drive

Chesterbrook, PA 19067


image of carton label

GNP MEDICATED WIPES 
witch hazel solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46122-055
Route of AdministrationTOPICAL, RECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL0.5 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
DIAZOLIDINYL UREA 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
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)

Revised: 6/2013
 
Amerisource Bergen

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