GNP MEDICATED WIPES- witch hazel solution

GNP Medicated Wipes by

Drug Labeling and Warnings

GNP Medicated Wipes by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

GNP MEDICATED WIPES 
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-055
Route of Administration	TOPICAL, RECTAL

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)