NDC Code(s) : 42507-333-16
Packager : HyVee Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42507-333
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINERAL OIL(UNII: T5L8T28FGP)
(MINERAL OIL - UNII:T5L8T28FGP) 		MINERAL OIL14 g in 100 g
PETROLATUM(UNII: 4T6H12BN9U)
(PETROLATUM - UNII:4T6H12BN9U) 		PETROLATUM74.9 g in 100 g
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE.25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID(UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
CORN OIL(UNII: 8470G57WFM)
GLYCERIN(UNII: PDC6A3C0OX)
LANOLIN(UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS(UNII: 884C3FA9HE)
METHYLPARABEN(UNII: A2I8C7HI9T)
PARAFFIN(UNII: I9O0E3H2ZE)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
THYME OIL(UNII: 2UK410MY6B)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
WHITE WAX(UNII: 7G1J5DA97F)
Product Characteristics
Color YELLOW (light) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42507-333-161 in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 12/02/2013

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients of Preparation H® Hemorrhoidal Ointment

Hemorrhoidal Ointment

Prevents Further Irritation

Prompt, Soothing Relief From Painful Burning, Itching and Discomfort

Protects Irritated Tissue

Shrinks Swollen Hemorrhoidal Tissue

Relieves Internal and External Discomfort

NET WT 2 OZ (57 g)

Hy Vee Hemorrhoidal Ointment 1.jpgHy Vee Hemorrhoidal Ointment 1.jpg