NDC Code(s) : 48951-3136-3
Packager : Uriel Pharmacy Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Crataegus OnopordonCrataegus Onopordon LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-3136
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HAWTHORN LEAF WITH FLOWER(UNII: 6OM09RPY36)
(HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) 		HAWTHORN LEAF WITH FLOWER3 [hp_X] in 1 mL
SELENICEREUS GRANDIFLORUS STEM(UNII: 7114SV0MYK)
(SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) 		SELENICEREUS GRANDIFLORUS STEM4 [hp_X] in 1 mL
BEEF HEART(UNII: P47W069U38)
(BEEF HEART - UNII:P47W069U38) 		BEEF HEART6 [hp_X] in 1 mL
GOLD(UNII: 79Y1949PYO)
(GOLD - UNII:79Y1949PYO) 		GOLD15 [hp_X] in 1 mL
ONOPORDUM ACANTHIUM FLOWER(UNII: AP97AUF88E)
(ONOPORDUM ACANTHIUM FLOWER - UNII:AP97AUF88E) 		ONOPORDUM ACANTHIUM FLOWER2 [hp_X] in 1 mL
PRIMULA VERIS FLOWER(UNII: W5BET37294)
(PRIMULA VERIS FLOWER - UNII:W5BET37294) 		PRIMULA VERIS FLOWER2 [hp_X] in 1 mL
HYOSCYAMUS NIGER LEAF(UNII: 32IT7G8BAW)
(HYOSCYAMUS NIGER LEAF - UNII:32IT7G8BAW) 		HYOSCYAMUS NIGER LEAF3 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PROPOLIS WAX(UNII: 6Y8XYV2NOF)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:48951-3136-360 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product09/01/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/01/2009

LABELER - Uriel Pharmacy Inc.(043471163)

Establishment
Name Address ID/FEI Business Operations
Uriel Pharmacy Inc. 043471163 manufacture(48951-3136)

PRINCIPAL DISPLAY PANEL

Crataegus Onopordon Liquid