NDC Code(s) : 37808-843-01
Packager : H E B

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

hemorrhoidalPhenylephrine HCl, Witch hazel GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37808-843
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE0.25 g in 100 g
WITCH HAZEL(UNII: 101I4J0U34)
(WITCH HAZEL - UNII:101I4J0U34) 		WITCH HAZEL50.0 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SULISOBENZONE(UNII: 1W6L629B4K)
EDETATE DISODIUM(UNII: 7FLD91C86K)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37808-843-011 in 1 CARTON
125 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 03/25/2011

PRINCIPAL DISPLAY PANEL

Compare to the active ingredients of Preparation H® Cooling Gel

HEMORRHOIDAL GEL

Fast Cooling Relief

Clear, Non-Greasy Formula with No Unpleasant Scent

Shrinks Swollen Hemorrhoidal Tissues

Prompt Cooling Relief from Painful Burning and Itching

Relieves External Discomfort

Hemorrhoidal Gel Carton Image 1Hemorrhoidal Gel Carton Image 1 Hemorrhoidal Gel Carton Image 1Hemorrhoidal Gel Carton Image 2