MedPath

Flea - Bug Bites

Flea - Bug Bites

Approved
Approval ID

83cd2059-5183-4f99-9fe5-7a4e2307914f

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

Aug 6, 2025

Manufacturers
FDA

Newton Laboratories, Inc.

DUNS: 788793610

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55714-4297
Product Classification
G
Generic Name
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
Product Specifications
Route of AdministrationORAL
Effective DateAugust 6, 2025
FDA Product Classification

INGREDIENTS (28)

Rancid BeefActive
Quantity: 30 [hp_X] in 1 mL
Code: 29SUH5R3HU
Classification: ACTIB
Azadirachta Indica BarkActive
Quantity: 16 [hp_X] in 1 mL
Code: G580B439YI
Classification: ACTIB
Apis MelliferaActive
Quantity: 15 [hp_X] in 1 mL
Code: 7S82P3R43Z
Classification: ACTIB
Araneus DiadematusActive
Quantity: 15 [hp_X] in 1 mL
Code: 6T6CO7R3Z5
Classification: ACTIB
Arnica MontanaActive
Quantity: 15 [hp_X] in 1 mL
Code: O80TY208ZW
Classification: ACTIB
Arsenic TrioxideActive
Quantity: 15 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
Bryonia Alba RootActive
Quantity: 15 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
Dieffenbachia SeguineActive
Quantity: 15 [hp_X] in 1 mL
Code: 01800C6E6B
Classification: ACTIB
Calendula Officinalis Flowering TopActive
Quantity: 15 [hp_X] in 1 mL
Code: 18E7415PXQ
Classification: ACTIB
Formica RufaActive
Quantity: 15 [hp_X] in 1 mL
Code: 55H0W83JO5
Classification: ACTIB
Grindelia Hirsutula Flowering TopActive
Quantity: 15 [hp_X] in 1 mL
Code: IDB0NAZ6AI
Classification: ACTIB
Hypericum PerforatumActive
Quantity: 15 [hp_X] in 1 mL
Code: XK4IUX8MNB
Classification: ACTIB
Lachesis Muta VenomActive
Quantity: 15 [hp_X] in 1 mL
Code: VSW71SS07I
Classification: ACTIB
Latrodectus MactansActive
Quantity: 15 [hp_X] in 1 mL
Code: XJJ7QA858R
Classification: ACTIB
Ledum Palustre TwigActive
Quantity: 15 [hp_X] in 1 mL
Code: 877L01IZ0P
Classification: ACTIB
Daphne Mezereum BarkActive
Quantity: 15 [hp_X] in 1 mL
Code: X2N6E405GV
Classification: ACTIB
Strychnos Nux-vomica SeedActive
Quantity: 15 [hp_X] in 1 mL
Code: 269XH13919
Classification: ACTIB
Pulex IrritansActive
Quantity: 15 [hp_X] in 1 mL
Code: L63DD62R8R
Classification: ACTIB
Toxicodendron Pubescens LeafActive
Quantity: 15 [hp_X] in 1 mL
Code: 6IO182RP7A
Classification: ACTIB
Lycosa TarantulaActive
Quantity: 15 [hp_X] in 1 mL
Code: 86M454L2TT
Classification: ACTIB
Theridion CurassavicumActive
Quantity: 15 [hp_X] in 1 mL
Code: 9Z8D3HEM8L
Classification: ACTIB
Cedar Leaf OilActive
Quantity: 15 [hp_X] in 1 mL
Code: BJ169U4NLG
Classification: ACTIB
Vespa CrabroActive
Quantity: 15 [hp_X] in 1 mL
Code: K3ALM8S49H
Classification: ACTIB
Echinacea, UnspecifiedActive
Quantity: 6 [hp_X] in 1 mL
Code: 4N9P6CC1DX
Classification: ACTIB
Hamamelis Virginiana Root Bark/stem BarkActive
Quantity: 6 [hp_X] in 1 mL
Code: T7S323PKJS
Classification: ACTIB
Solidago Virgaurea Flowering TopActive
Quantity: 6 [hp_X] in 1 mL
Code: 5405K23S50
Classification: ACTIB
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/7/2025

PACKAGE LABEL.PRINCIPAL

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/16/2019

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/21/2025

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

LOINC: 55106-9Updated: 7/21/2025

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hamamelis 6x, Solidago 6x, Apis mel. 15x, Aranea 15x, Arnica 15x, Arsenicum alb. 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 hisp. 15x, Theridion 15x, Thuja occ. 15x, Vespa 15x, Azadirachta 16x, Pyrogenium 30x.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/5/2012

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/4/2019

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/16/2019

QUESTIONS SECTION

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

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2019

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

LOINC: 53414-9Updated: 9/4/2019

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ifpregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/4/2019

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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