Bites - Stings DailyMed Label

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Pyrogenium 30x, Apis mel. 15x, Aranea 15x, Arnica 15x, Arsenicum alb. 15x, Azadirachta 15x, Bryonia 15x, Caladium seguinum 15x, Calendula 15, 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, Echinacea 3x, Hamamelis 3x, Solidago 3x.

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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

PACKAGE LABEL

Label Images#

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-8003-1	2020-01-31	C162847	48780-1	9d75b9d0-d2c4-f424-e053-dadaa90a57ce	Bites - Stings

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-8003-1	Bites - Stings	29.57 mL in 1 BOTTLE, GLASS	LIQUID	29.57		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-8003	BITES - STINGS (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.]	1	Legacy NDC, 1 package rows	20140429_e5c4c6c3-d282-560c-e372-e545765037fc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Apis Mellifera	ACTIVE INGREDIENT	7S82P3R43Z	1
Araneus Diadematus	ACTIVE INGREDIENT	6T6CO7R3Z5	1
Arnica Montana	ACTIVE INGREDIENT	O80TY208ZW	1
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Azadirachta Indica Bark	ACTIVE INGREDIENT	G580B439YI	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Calendula Officinalis Flowering Top	ACTIVE INGREDIENT	18E7415PXQ	1
Citharacanthus Spinicrus	ACTIVE INGREDIENT	3Y5X6RT823	1
Daphne Mezereum Bark	ACTIVE INGREDIENT	X2N6E405GV	1
Dieffenbachia Seguine	ACTIVE INGREDIENT	01800C6E6B	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Formica Rufa	ACTIVE INGREDIENT	55H0W83JO5	1
Grindelia Hirsutula Flowering Top	ACTIVE INGREDIENT	IDB0NAZ6AI	1
Hamamelis Virginiana Root Bark/stem Bark	ACTIVE INGREDIENT	T7S323PKJS	1
Hypericum Perforatum	ACTIVE INGREDIENT	XK4IUX8MNB	1
Lachesis Muta Venom	ACTIVE INGREDIENT	VSW71SS07I	1
Latrodectus Mactans	ACTIVE INGREDIENT	XJJ7QA858R	1
Ledum Palustre Twig	ACTIVE INGREDIENT	877L01IZ0P	1
Lycosa Tarantula	ACTIVE INGREDIENT	86M454L2TT	1
Pulex Irritans	ACTIVE INGREDIENT	L63DD62R8R	1
Rancid Beef	ACTIVE INGREDIENT	29SUH5R3HU	1
Solidago Virgaurea Flowering Top	ACTIVE INGREDIENT	5405K23S50	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Theridion Curassavicum	ACTIVE INGREDIENT	9Z8D3HEM8L	1
Thuja Occidentalis Leafy Twig	ACTIVE INGREDIENT	1NT28V9397	1
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	1
Vespa Crabro	ACTIVE INGREDIENT	K3ALM8S49H	1
Apis Mellifera	ACTIVE MOIETY	7S82P3R43Z	1
Araneus Diadematus	ACTIVE MOIETY	6T6CO7R3Z5	1
Arnica Montana	ACTIVE MOIETY	O80TY208ZW	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Azadirachta Indica Bark	ACTIVE MOIETY	G580B439YI	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Calendula Officinalis Flowering Top	ACTIVE MOIETY	18E7415PXQ	1
Citharacanthus Spinicrus	ACTIVE MOIETY	3Y5X6RT823	1
Daphne Mezereum Bark	ACTIVE MOIETY	X2N6E405GV	1
Dieffenbachia Seguine	ACTIVE MOIETY	01800C6E6B	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Formica Rufa	ACTIVE MOIETY	55H0W83JO5	1
Grindelia Hirsutula Flowering Top	ACTIVE MOIETY	IDB0NAZ6AI	1
Hamamelis Virginiana Root Bark/stem Bark	ACTIVE MOIETY	T7S323PKJS	1
Hypericum Perforatum	ACTIVE MOIETY	XK4IUX8MNB	1
Lachesis Muta Venom	ACTIVE MOIETY	VSW71SS07I	1
Latrodectus Mactans	ACTIVE MOIETY	XJJ7QA858R	1
Ledum Palustre Twig	ACTIVE MOIETY	877L01IZ0P	1
Lycosa Tarantula	ACTIVE MOIETY	86M454L2TT	1
Pulex Irritans	ACTIVE MOIETY	L63DD62R8R	1
Rancid Beef	ACTIVE MOIETY	29SUH5R3HU	1
Solidago Virgaurea Flowering Top	ACTIVE MOIETY	5405K23S50	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Theridion Curassavicum	ACTIVE MOIETY	9Z8D3HEM8L	1
Thuja Occidentalis Leafy Twig	ACTIVE MOIETY	1NT28V9397	1
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	1
Vespa Crabro	ACTIVE MOIETY	K3ALM8S49H	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	1

Products#

Bites - Stings
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
Arsenic Cation (3+)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-8003	55714-8003-1

Ingredients#

Name, UNII, Kind table
Name	UNII	Kind
Rancid Beef	29SUH5R3HU	ACTIB
Apis Mellifera	7S82P3R43Z	ACTIB
Araneus Diadematus	6T6CO7R3Z5	ACTIB
Arnica Montana	O80TY208ZW	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIM
Azadirachta Indica Bark	G580B439YI	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Dieffenbachia Seguine	01800C6E6B	ACTIB
Calendula Officinalis Flowering Top	18E7415PXQ	ACTIB
Formica Rufa	55H0W83JO5	ACTIB
Grindelia Hirsutula Flowering Top	IDB0NAZ6AI	ACTIB
Hypericum Perforatum	XK4IUX8MNB	ACTIB
Lachesis Muta Venom	VSW71SS07I	ACTIB
Latrodectus Mactans	XJJ7QA858R	ACTIB
Ledum Palustre Twig	877L01IZ0P	ACTIB
Daphne Mezereum Bark	X2N6E405GV	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Pulex Irritans	L63DD62R8R	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Citharacanthus Spinicrus	3Y5X6RT823	ACTIB
Lycosa Tarantula	86M454L2TT	ACTIB
Theridion Curassavicum	9Z8D3HEM8L	ACTIB
Thuja Occidentalis Leafy Twig	1NT28V9397	ACTIB
Vespa Crabro	K3ALM8S49H	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Hamamelis Virginiana Root Bark/stem Bark	T7S323PKJS	ACTIB
Solidago Virgaurea Flowering Top	5405K23S50	ACTIB
Alcohol	3K9958V90M	IACT

Complete SPL Sections#