FLEA - BUG BITES- pyrogenium, apis mel., aranea diadema, arnica, arsenicum alb., azadirachta indica, bryonia, caladium seguinum, calendula, formica, grindelia, hypericum, lachesis, latrodectus mactans, ledum, mezereum, nux vom., pulex irritans, rhus toxicodendron, tarentula cubensis, tarentula hispana, theridion, thuja occ., vespa crabro, echinacea, hamamelis, solidago liquid 
Newton Laboratories, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Flea - Bug Bites

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Pets, under 50 lbs., give 3 drops by mouth (50 to 500 lbs. - 6 drops,over 500 lbs. - 1/2 teaspoon) as needed or as directed by a health professional. Place in mouth or purified water.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hamamelis 6x, Solidago 6x, Apis mel. 15x, Aranea 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 mac. 15x, Ledum 15x, Mezereum 15x, Nux vom. 15x, Pulex irr. 15x, Rhus tox. 15x, Tarentula cub.15x, Tarentula hisp. 15x, Theridion 15x, Thuja occ. 15x, Vespa 15x, Pyrogenium 30x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net  Questions?  1.800.448.7256 
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS:  Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL

package label
package label

FLEA - BUG BITES 
pyrogenium, apis mel., aranea diadema, arnica, arsenicum alb., azadirachta indica, bryonia, caladium seguinum, calendula, formica, grindelia, hypericum, lachesis, 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 TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-4259
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Rancid Beef (UNII: 29SUH5R3HU) (Rancid Beef - UNII:29SUH5R3HU) Rancid Beef30 [hp_X]  in 1 mL
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera15 [hp_X]  in 1 mL
Araneus Diadematus (UNII: 6T6CO7R3Z5) (Araneus Diadematus - UNII:6T6CO7R3Z5) Araneus Diadematus15 [hp_X]  in 1 mL
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana15 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
Azadirachta Indica Bark (UNII: G580B439YI) (Azadirachta Indica Bark - UNII:G580B439YI) Azadirachta Indica Bark15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Dieffenbachia Seguine (UNII: 01800C6E6B) (Dieffenbachia Seguine - UNII:01800C6E6B) Dieffenbachia Seguine15 [hp_X]  in 1 mL
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top15 [hp_X]  in 1 mL
Formica Rufa (UNII: 55H0W83JO5) (Formica Rufa - UNII:55H0W83JO5) Formica Rufa15 [hp_X]  in 1 mL
Grindelia Hirsutula Flowering Top (UNII: IDB0NAZ6AI) (Grindelia Hirsutula Flowering Top - UNII:IDB0NAZ6AI) Grindelia Hirsutula Flowering Top15 [hp_X]  in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum15 [hp_X]  in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 mL
Latrodectus Mactans (UNII: XJJ7QA858R) (Latrodectus Mactans - UNII:XJJ7QA858R) Latrodectus Mactans15 [hp_X]  in 1 mL
Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig15 [hp_X]  in 1 mL
Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Pulex Irritans (UNII: L63DD62R8R) (Pulex Irritans - UNII:L63DD62R8R) Pulex Irritans15 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
Citharacanthus Spinicrus (UNII: 3Y5X6RT823) (Citharacanthus Spinicrus - UNII:3Y5X6RT823) Citharacanthus Spinicrus15 [hp_X]  in 1 mL
Lycosa Tarantula (UNII: 86M454L2TT) (Lycosa Tarantula - UNII:86M454L2TT) Lycosa Tarantula15 [hp_X]  in 1 mL
Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum15 [hp_X]  in 1 mL
Cedar Leaf Oil (UNII: BJ169U4NLG) (Cedar Leaf Oil - UNII:BJ169U4NLG) Cedar Leaf Oil15 [hp_X]  in 1 mL
Vespa Crabro (UNII: K3ALM8S49H) (Vespa Crabro - UNII:K3ALM8S49H) Vespa Crabro15 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS) (Hamamelis Virginiana Root Bark/stem Bark - UNII:T7S323PKJS) Hamamelis Virginiana Root Bark/stem Bark3 [hp_X]  in 1 mL
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4259-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4259-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-4259-014.78 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/15/201112/31/2018
FLEA - BUG BITES 
pyrogenium, apis mel., aranea diadema, arnica, arsenicum alb., azadirachta indica, bryonia, caladium seguinum, calendula, formica, grindelia, hypericum, lachesis, 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 TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-4287
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Rancid Beef (UNII: 29SUH5R3HU) (Rancid Beef - UNII:29SUH5R3HU) Rancid Beef30 [hp_X]  in 1 mL
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera15 [hp_X]  in 1 mL
Araneus Diadematus (UNII: 6T6CO7R3Z5) (Araneus Diadematus - UNII:6T6CO7R3Z5) Araneus Diadematus15 [hp_X]  in 1 mL
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana15 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
Azadirachta Indica Bark (UNII: G580B439YI) (Azadirachta Indica Bark - UNII:G580B439YI) Azadirachta Indica Bark15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Dieffenbachia Seguine (UNII: 01800C6E6B) (Dieffenbachia Seguine - UNII:01800C6E6B) Dieffenbachia Seguine15 [hp_X]  in 1 mL
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top15 [hp_X]  in 1 mL
Formica Rufa (UNII: 55H0W83JO5) (Formica Rufa - UNII:55H0W83JO5) Formica Rufa15 [hp_X]  in 1 mL
Grindelia Hirsutula Flowering Top (UNII: IDB0NAZ6AI) (Grindelia Hirsutula Flowering Top - UNII:IDB0NAZ6AI) Grindelia Hirsutula Flowering Top15 [hp_X]  in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum15 [hp_X]  in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom15 [hp_X]  in 1 mL
Latrodectus Mactans (UNII: XJJ7QA858R) (Latrodectus Mactans - UNII:XJJ7QA858R) Latrodectus Mactans15 [hp_X]  in 1 mL
Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig15 [hp_X]  in 1 mL
Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Pulex Irritans (UNII: L63DD62R8R) (Pulex Irritans - UNII:L63DD62R8R) Pulex Irritans15 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
Citharacanthus Spinicrus (UNII: 3Y5X6RT823) (Citharacanthus Spinicrus - UNII:3Y5X6RT823) Citharacanthus Spinicrus15 [hp_X]  in 1 mL
Lycosa Tarantula (UNII: 86M454L2TT) (Lycosa Tarantula - UNII:86M454L2TT) Lycosa Tarantula15 [hp_X]  in 1 mL
Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum15 [hp_X]  in 1 mL
Cedar Leaf Oil (UNII: BJ169U4NLG) (Cedar Leaf Oil - UNII:BJ169U4NLG) Cedar Leaf Oil15 [hp_X]  in 1 mL
Vespa Crabro (UNII: K3ALM8S49H) (Vespa Crabro - UNII:K3ALM8S49H) Vespa Crabro15 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified6 [hp_X]  in 1 mL
Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS) (Hamamelis Virginiana Root Bark/stem Bark - UNII:T7S323PKJS) Hamamelis Virginiana Root Bark/stem Bark6 [hp_X]  in 1 mL
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4287-130 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/14/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE, API MANUFACTURE

Revised: 1/2019
Document Id: a8b68b79-0ca2-4010-9c76-a2311c1fcf75
Set id: 7fb812b3-47af-5aa1-3bee-6500290c9f4b
Version: 3
Effective Time: 20190114
 
Newton Laboratories, Inc.