NDC Code(s) : 60986-2035-5, 60986-2035-3
Packager : MARCO PHARMA INTERNATIONAL LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ABCACONITUM NAPELLUS, BELLADONNA, CHAMOMILLA LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60986-2035
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS(UNII: U0NQ8555JD)
(ACONITUM NAPELLUS - UNII:U0NQ8555JD) 		ACONITUM NAPELLUS3 [hp_X] in 100 mL
MATRICARIA RECUTITA(UNII: G0R4UBI2ZZ)
(MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) 		MATRICARIA RECUTITA3 [hp_X] in 100 mL
BELLADONNA LEAF(UNII: 6GZW20TIOI)
(BELLADONNA LEAF - UNII:6GZW20TIOI) 		BELLADONNA LEAF3 [hp_X] in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60986-2035-520 mL in 1 BOTTLE Type 0: Not a Combination Product27/01/2015
2NDC:60986-2035-350 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product12/03/2024
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/22/2015

LABELER - MARCO PHARMA INTERNATIONAL LLC(161994277)

REGISTRANT - MARCO PHARMA INTERNATIONAL LLC(161994277)

Establishment
Name Address ID/FEI Business Operations
NESTMANN PHARMA 323426262 manufacture(60986-2035)

PRINCIPAL DISPLAY PANEL

ABC_M10032