GNP MEDICATED WIPES - witch hazel solution 
Amerisource Bergen

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 Facts

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

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

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 Type HUMAN OTC DRUG 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 (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 0.5 mg  in 1 mg
Inactive Ingredients
Ingredient Name Strength
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 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)

Revised: 6/2013
Document Id: 1b91f562-e8d2-42e9-9bea-ea24ec7234bf
Set id: 3572c13c-9dab-4ffb-80ca-d4141bf8fdff
Version: 2
Effective Time: 20130630
 
Amerisource Bergen