INSECT BITES - rancid beef, apis mellifera, araneus diadematus, arnica montana, arsenic trioxide, azadirachta indica bark, bryonia alba root, dieffenbachia seguine, calendula officinalis flowering top, formica rufa, grindelia hirsutula flowering top, hypericum perforatum, lachesis muta venom, latrodectus mactans, ledum palustre twig, daphne mezereum bark, strychnos nux-vomica seed, pulex irritans, toxicodendron pubescens leaf, citharacanthus spinicrus, lycosa tarantula, theridion curassavicum, thuja occidentalis leafy twig, vespa crabro, echinacea, unspecified, hamamelis virginiana root bark/stem bark and solidago virgaurea flowering top liquid 
Newton Laboratories, 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.

----------

Insect Bites

INDICATIONS & USAGE SECTION

Insect Bites   Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.                      

DOSAGE & ADMINISTRATION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.   Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.                       

ACTIVE INGREDIENT SECTION

Pyrogenium 30x, Apis mel. 15x, Aranea diadema 15x, Arnica 15x, Arsenicum alb 15x, Azadirachta indica 15x, Bryonia 15x, Caladium seguinum  15x, Calendula 15x, Formica 15x, Grindelia 15x, Hypericum  15x, Lachesis 15x, Latrodectus mactans 15x, Ledum 15x, Mezereum  15x, Nux vom. 15x, Pulex irritans 15x, Rhus toxicodendron 15x, Tarentula cubensis 15x, Tarentula hispana 15x, Theridion 15x, Thuja occ. 15x, Vespa crabro 15x, Echinacea 3x,  Hamamelis 3x, Solidago 3x.           

PURPOSE SECTION

Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.

INACTIVE INGREDIENT SECTION

USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.        

QUESTIONS? SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256          

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.        

PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.                

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.           

PACKAGE LABEL

Package Label

INSECT BITES  
pyrogenium, apis mel., aranea diadema, arnica, arsenicum alb, azadirachta indica, bryonia, caladium seguinum , calendula, formica, grindelia, hypericum , lachesis 15x, latrodectus mactans, ledum, mezereum , nux vom., pulex irritans, rhus toxicodendron, tarentula cubensis, tarentula hispana, theridion, thuja occ., vespa crabro, echinacea, hamamelis solidago liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55714-4474
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Rancid Beef (Rancid Beef) Rancid Beef30 [hp_X]  in 1 mL
Apis Mellifera (Apis Mellifera) Apis Mellifera15 [hp_X]  in 1 mL
Araneus Diadematus (Araneus Diadematus) Araneus Diadematus15 [hp_X]  in 1 mL
Arnica Montana (Arnica Montana) Arnica Montana15 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide15 [hp_X]  in 1 mL
Azadirachta Indica Bark (Azadirachta Indica Bark) Azadirachta Indica Bark15 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root15 [hp_X]  in 1 mL
Dieffenbachia Seguine (Dieffenbachia Seguine) Dieffenbachia Seguine15 [hp_X]  in 1 mL
Calendula Officinalis Flowering Top (Calendula Officinalis Flowering Top) Calendula Officinalis Flowering Top15 [hp_X]  in 1 mL
Formica Rufa (Formica Rufa) Formica Rufa15 [hp_X]  in 1 mL
Grindelia Hirsutula Flowering Top (Grindelia Hirsutula Flowering Top) Grindelia Hirsutula Flowering Top15 [hp_X]  in 1 mL
Hypericum Perforatum (Hypericum Perforatum) Hypericum Perforatum15 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom15 [hp_X]  in 1 mL
Latrodectus Mactans (Latrodectus Mactans) Latrodectus Mactans15 [hp_X]  in 1 mL
Ledum Palustre Twig (Ledum Palustre Twig) Ledum Palustre Twig15 [hp_X]  in 1 mL
Daphne Mezereum Bark (Daphne Mezereum Bark) Daphne Mezereum Bark15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Pulex Irritans (Pulex Irritans) Pulex Irritans15 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
Citharacanthus Spinicrus (Citharacanthus Spinicrus) Citharacanthus Spinicrus15 [hp_X]  in 1 mL
Lycosa Tarantula (Lycosa Tarantula) Lycosa Tarantula15 [hp_X]  in 1 mL
Theridion Curassavicum (Theridion Curassavicum) Theridion Curassavicum15 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig) Thuja Occidentalis Leafy Twig15 [hp_X]  in 1 mL
Vespa Crabro (Vespa Crabro) Vespa Crabro15 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Hamamelis Virginiana Root Bark/stem Bark (Hamamelis Virginiana Root Bark/stem Bark) Hamamelis Virginiana Root Bark/stem Bark3 [hp_X]  in 1 mL
Solidago Virgaurea Flowering Top (Solidago Virgaurea Flowering Top) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4474-129.57 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4474)

Revised: 6/2011
Document Id: 284aa2d0-96fc-dbbc-0c64-84092bad7f14
Set id: b34eb42a-fca0-2b42-1429-886121bd5178
Version: 2
Effective Time: 20110601
 
Newton Laboratories, Inc.