DailyMed - BITING INSECT ANTIGENS (apis mellifica, hypericum perforatum, ledum palustre, cimex lectularius (bed bug), formica rufa (red wood ants), pulex irritans (human flea), vespa crabro- hornet, wasp liquid

NDC Code(s): 43857-0263-1
Packager: BioActive Nutritional, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 7, 2023

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ACTIVE INGREDIENTS:
Apis Mellifica 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Cimex Lectularius (Bed Bug) 15X, 30X, Formica Rufa (Red Wood Ants) 15X, 30X, Pulex Irritans (Human Flea) 15X, 30X, Vespa Crabro ...

Apis Mellifica 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Cimex Lectularius (Bed Bug) 15X, 30X, Formica Rufa (Red Wood Ants) 15X, 30X, Pulex Irritans (Human Flea) 15X, 30X, Vespa Crabro (Hornet, Wasp) 15X, 30X.
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INDICATIONS:
For the relief of allergies due to biting insects.

For the relief of allergies due to biting insects.
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WARNINGS:
If pregnant or breast-feeding, ask a health care 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 ...

If pregnant or breast-feeding, ask a health care 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.
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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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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DIRECTIONS:
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
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INDICATIONS:
For the relief of allergies due to biting insects.

For the relief of allergies due to biting insects.
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INACTIVE INGREDIENTS:
Demineralized Water, 25% Ethanol.

Demineralized Water, 25% Ethanol.
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QUESTIONS:
Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 - bioactivenutritional.com

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

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PACKAGE LABEL DISPLAY:
BIOActive Nutritional - BITING INSECT ANTIGENS - HOMEOPATHIC - 1 FL OZ (30 ml)

BIOActive Nutritional

BITING INSECT ANTIGENS

HOMEOPATHIC

1 FL OZ (30 ml)

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INGREDIENTS AND APPEARANCE

Product Information

BITING INSECT ANTIGENS apis mellifica, hypericum perforatum, ledum palustre, cimex lectularius (bed bug), formica rufa (red wood ants), pulex irritans (human flea), vespa crabro (hornet, wasp) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0263
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X] in 1 mL
HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM WHOLE	12 [hp_X] in 1 mL
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	RHODODENDRON TOMENTOSUM LEAFY TWIG	12 [hp_X] in 1 mL
CIMEX LECTULARIUS (UNII: W66P4K3SGW) (CIMEX LECTULARIUS - UNII:W66P4K3SGW)	CIMEX LECTULARIUS	15 [hp_X] in 1 mL
FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5)	FORMICA RUFA	15 [hp_X] in 1 mL
PULEX IRRITANS (UNII: L63DD62R8R) (PULEX IRRITANS - UNII:L63DD62R8R)	PULEX IRRITANS	15 [hp_X] in 1 mL
VESPA CRABRO (UNII: K3ALM8S49H) (VESPA CRABRO - UNII:K3ALM8S49H)	VESPA CRABRO	15 [hp_X] 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:43857-0263-1	1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/05/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/16/2014

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0263) , api manufacture(43857-0263) , label(43857-0263) , pack(43857-0263)

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Published Date (What is this?)	Version	Files
Jun 8, 2023	6 (current)	download
May 19, 2021	5	download
Apr 7, 2017	4	download
Jun 23, 2014	3	download

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