NDC Code(s) : 0573-2841-08
Packager : Pfizer Consumer Healthcare

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Preparation H Totables Burning Reliefphenylephrine hydrochloride and witch hazel GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0573-2841
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE2.5 mg in 1 g
WITCH HAZEL(UNII: 101I4J0U34)
(WITCH HAZEL - UNII:101I4J0U34) 		WITCH HAZEL500 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
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)
SULISOBENZONE(UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0573-2841-083 in 1 CARTON
15.7 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part346 10/10/2010

PRINCIPAL DISPLAY PANEL

NEW

PREPARATION H ®
HEMORRHOIDAL GEL

Tōtables ™

Burning Relief Gel
CLEAR NON-GREASY FORMULA

3 Mini-Prep™ Tubes
NET WT 0.2 OZ (5.7 g) EACH

Principal Display Panel - 3 5.7 g Tube Carton