Bug Bites - Itch Stopper

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:02

Label at a glance#

ProductBug Bites - Itch Stopper

Active ingredientRancid 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, Solidago Virgaurea Flowering Top

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - 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 15, 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.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

QUESTIONS SECTION

OTC - 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.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
55714-2275-0	2020-01-31	C162847	48780-1	9d75b9d0-affc-f424-e053-dadaa90a57ce	Bug Bites - Itch Stopper
55714-2275-1	2020-01-31	C162847	48780-1	9d75b9d0-affc-f424-e053-dadaa90a57ce	Bug Bites - Itch Stopper
55714-2275-2	2020-01-31	C162847	48780-1	9d75b9d0-affc-f424-e053-dadaa90a57ce	Bug Bites - Itch Stopper

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55714-2275-0	Bug Bites - Itch Stopper	7.08 g in 1 BOTTLE, GLASS	PELLET	7.08	1
55714-2275-1	Bug Bites - Itch Stopper	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35	1
55714-2275-2	Bug Bites - Itch Stopper	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-2275	BUG BITES - ITCH STOPPER (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) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 3 package rows	20131016_b6dc19e4-f1cf-a9cc-458f-952f656ef204.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
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

Bug Bites - Itch Stopper
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
Rancid Beef
Apis Mellifera
Araneus Diadematus
Arnica Montana
Arsenic Trioxide
Arsenic Cation (3+)
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
Solidago Virgaurea Flowering Top
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-2275	55714-2275-1, 55714-2275-2, 55714-2275-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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	ACTIB
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
Sucrose	C151H8M554	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
da159cbd-50d9-a529-fd44-f595bd34f9d5			b6dc19e4-f1cf-a9cc-458f-952f656ef204	2011-03-01	Warnings	Exact identifier spl id: da159cbd-50d9-a529-fd44-f595bd34f9d5 spl set id: b6dc19e4-f1cf-a9cc-458f-952f656ef204

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.