Nut Antigens (Almond (Nut), Cashew (Nut), Black Walnut (Nut), Pecan (Nut), Coconut, Oleum Olea Europaea, Chestnut (Nut), Water Chestnut (Nut), Pinenut (Nut), Macadamia (Nut), Pistachio (Nut), -

NDC	44911-0402-1
Set ID	e95845f0-26d1-4190-bb45-e5f276a2bba4
Category	HUMAN OTC DRUG LABEL
Packager	Energique, Inc.
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS:

(in each drop): 8.33% of Arsenicum Album 12X, 15X, Carya Alba 12C, 18C, Lycopodium Clavatum 12X, 15X, Pulsatilla (Vulgaris) 12X, 15X, Sulphur 12X, 15X; 2.78% of Brazil Nut (Nut) 15X, 18X, 30X, English Walnut (Nut) 15X, 18X, 30X, Hazelnut (Nut) 15X, 18X, 30X, Peanut (Nut) 15X, 18X, 30X; 2.08% of Almond (Nut) 12X, 15X, 18X, 30X, Black Walnut (Nut) 12X, 15X, 18X, 30X, Cashew (Nut) 12X, 15X, 18X, 30X, Chestnut (Nut) 12X, 15X, 18X, 30X, Coconut 12X, 15X, 18X, 30X, Macadamia (Nut) 12X, 15X, 18X, 30X, Oleum Olea Europaea 12X, 15X, 18X, 30X, Pecan (Nut) 12X, 15X, 18X, 30X, Pinenut (Nut) 12X, 15X, 18X, 30X, Pistachio (Nut) 12X, 15X, 18X, 30X, Water Chestnut (Nut) 12X, 15X, 18X, 30X.
INDICATIONS:

For temporary relief of sensitivities due to nuts.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
WARNINGS:

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.
KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DIRECTIONS:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.
INDICATIONS:

For temporary relief of sensitivities due to nuts.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.
QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.869.8078
PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

NUT

ANTIGENS

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

NUT ANTIGENS
almond (nut), cashew (nut), black walnut (nut), pecan (nut), coconut, oleum olea europaea, chestnut (nut), water chestnut (nut), pinenut (nut), macadamia (nut), pistachio (nut), peanut (nut), english walnut (nut), brazil nut (nut), hazelnut (nut), arsenicum album, lycopodium clavatum, pulsatilla (vulgaris), sulphur, carya alba liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44911-0402
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALMOND (UNII: 3Z252A2K9G) (ALMOND - UNII:3Z252A2K9G)	ALMOND	12 [hp_X] in 1 mL
CASHEW (UNII: 3H5U5CX7KO) (CASHEW - UNII:3H5U5CX7KO)	CASHEW	12 [hp_X] in 1 mL
BLACK WALNUT (UNII: 02WM57RXZJ) (BLACK WALNUT - UNII:02WM57RXZJ)	BLACK WALNUT	12 [hp_X] in 1 mL
PECAN (UNII: F14P91GB5F) (PECAN - UNII:F14P91GB5F)	PECAN	12 [hp_X] in 1 mL
COCONUT (UNII: 3RT3536DHY) (COCONUT - UNII:3RT3536DHY)	COCONUT	12 [hp_X] in 1 mL
OLIVE OIL (UNII: 6UYK2W1W1E) (OLIVE OIL - UNII:6UYK2W1W1E)	OLIVE OIL	12 [hp_X] in 1 mL
CHINESE CHESTNUT (UNII: 2774MIM2V7) (CHINESE CHESTNUT - UNII:2774MIM2V7)	CHINESE CHESTNUT	12 [hp_X] in 1 mL
TRAPA BICORNIS SEED (UNII: 5S8I11UZ7P) (TRAPA BICORNIS SEED - UNII:5S8I11UZ7P)	TRAPA BICORNIS SEED	12 [hp_X] in 1 mL
PINE NUT (UNII: 1085871XJA) (PINE NUT - UNII:1085871XJA)	PINE NUT	12 [hp_X] in 1 mL
MACADAMIA NUT (UNII: Y5432RGW8N) (MACADAMIA NUT - UNII:Y5432RGW8N)	MACADAMIA NUT	12 [hp_X] in 1 mL
PISTACHIO (UNII: 6815CPT6ZJ) (PISTACHIO - UNII:6815CPT6ZJ)	PISTACHIO	12 [hp_X] in 1 mL
PEANUT (UNII: QE1QX6B99R) (PEANUT - UNII:QE1QX6B99R)	PEANUT	15 [hp_X] in 1 mL
ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7)	ENGLISH WALNUT	15 [hp_X] in 1 mL
BRAZIL NUT (UNII: XKR79OET1K) (BRAZIL NUT - UNII:XKR79OET1K)	BRAZIL NUT	15 [hp_X] in 1 mL
AMERICAN HAZELNUT (UNII: IUP4S55D8S) (AMERICAN HAZELNUT - UNII:IUP4S55D8S)	AMERICAN HAZELNUT	15 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X] in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X] in 1 mL
MOCKERNUT (UNII: 339AZK21GR) (MOCKERNUT - UNII:339AZK21GR)	MOCKERNUT	12 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:44911-0402-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/14/2016

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(44911-0402) , api manufacture(44911-0402) , label(44911-0402) , pack(44911-0402)

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Medic

NUT ANTIGENS (ALMOND (NUT), CASHEW (NUT), BLACK WALNUT (NUT), PECAN (NUT), COCONUT, OLEUM OLEA EUROPAEA, CHESTNUT (NUT), WATER CHESTNUT (NUT), PINENUT (NUT), MACADAMIA (NUT), PISTACHIO (NUT),

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