NDC Code(s) : 60986-1003-3, 60986-1003-4
Packager : Marco Pharma International LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AllernestFormicum acidum, Lachesis mutus, luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai racemosa,Galphimia glauca, thuja occidentalis, Urtica dicica and Cardiospermum LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60986-1003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FORMIC ACID(UNII: 0YIW783RG1)
(FORMIC ACID - UNII:0YIW783RG1) 		FORMIC ACID12 [hp_X] in 1 mL
LACHESIS MUTA VENOM(UNII: VSW71SS07I)
(LACHESIS MUTA VENOM - UNII:VSW71SS07I) 		LACHESIS MUTA VENOM8 [hp_X] in 1 mL
LUFFA OPERCULATA FRUIT(UNII: C4MO6809HU)
(LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) 		LUFFA OPERCULATA FRUIT6 [hp_X] in 1 mL
KEROSENE(UNII: 1C89KKC04E)
(KEROSENE - UNII:1C89KKC04E) 		KEROSENE6 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF(UNII: 6IO182RP7A)
(TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) 		TOXICODENDRON PUBESCENS LEAF6 [hp_X] in 1 mL
ARALIA RACEMOSA ROOT(UNII: T90W4582DU)
(ARALIA RACEMOSA ROOT - UNII:T90W4582DU) 		ARALIA RACEMOSA ROOT4 [hp_X] in 1 mL
GALPHIMIA GLAUCA FLOWERING TOP(UNII: 93PH5Q8M7E)
(GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) 		GALPHIMIA GLAUCA FLOWERING TOP4 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG(UNII: 1NT28V9397)
(THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) 		THUJA OCCIDENTALIS LEAFY TWIG4 [hp_X] in 1 mL
URTICA DIOICA(UNII: 710FLW4U46)
(URTICA DIOICA - UNII:710FLW4U46) 		URTICA DIOICA4 [hp_X] in 1 mL
CARDIOSPERMUM HALICACABUM FLOWERING TOP(UNII: MZP2508BRR)
(CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) 		CARDIOSPERMUM HALICACABUM FLOWERING TOP3 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60986-1003-350 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product27/02/2018
2NDC:60986-1003-4100 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product27/02/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 11/18/2011

LABELER - Marco Pharma International LLC.(161994277)

REGISTRANT - Marco Pharma International LLC.(161994277)

Establishment
Name Address ID/FEI Business Operations
Nestmann Pharma GmbH 323426262 manufacture(60986-1003)

PRINCIPAL DISPLAY PANEL

N8_60986-1003-3-4