Biting Insect Antigens: Homeopathic Product Information

BITING INSECT ANTIGENS- apis mellifera, culex pipiens, hypericum perforatum whole, ledum palustre twig, pediculus humanus var. capitis, cimex lectularius, formica rufa, pulex irritans and vespa crabro liquid
Energique, Inc.

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.

ACTIVE INGREDIENTS:

(in each drop): 12.46% of Apis Mellifica 12X, 15X, Hypericum Perforatum 12X, 15X, Ledum Palustre 12X, 15X; Pediculus Capitis 12X, 15X,0.10% of Culex Musca12X,15X; 0.05% of Biting Insect Allersodes (Cimex Lectularius, Formica Rufa, Pulex Irritans, Vespa Crabro) 15X, 30X.

INDICATIONS:

May temporarily relieve symptoms associated with biting insect reactions.**

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

WARNINGS:

If pregnant or breast-feeding, 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:

May temporarily relieve symptoms associated with biting insect reactions.**

**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

BITING INSECT

ANTIGENS

1 fl. oz. (30 ml)

Biting Insect Antigens
(click image for full-size original)

BITING INSECT ANTIGENS
apis mellifica, culex musca, hypericum perforatum, ledum palustre, pediculus capitis, cimex lectularius, formica rufa, pulex irritans, vespa crabro liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0648
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 12 [hp_X] in 1 mL
CULEX PIPIENS (CULEX PIPIENS) CULEX PIPIENS 12 [hp_X] in 1 mL
HYPERICUM PERFORATUM WHOLE (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM WHOLE 12 [hp_X] in 1 mL
LEDUM PALUSTRE TWIG (LEDUM PALUSTRE TWIG) LEDUM PALUSTRE TWIG 12 [hp_X] in 1 mL
PEDICULUS HUMANUS VAR. CAPITIS (PEDICULUS HUMANUS VAR. CAPITIS) PEDICULUS HUMANUS VAR. CAPITIS 12 [hp_X] in 1 mL
CIMEX LECTULARIUS (CIMEX LECTULARIUS) CIMEX LECTULARIUS 15 [hp_X] in 1 mL
FORMICA RUFA (FORMICA RUFA) FORMICA RUFA 15 [hp_X] in 1 mL
PULEX IRRITANS (PULEX IRRITANS) PULEX IRRITANS 15 [hp_X] in 1 mL
VESPA CRABRO (VESPA CRABRO) VESPA CRABRO 15 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44911-0648-1 30 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/07/2021
Labeler — Energique, Inc. (789886132)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (44911-0648), api manufacture (44911-0648), label (44911-0648), pack (44911-0648)

Revised: 10/2021 Energique, Inc.

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