FDA.reportPublic FDA data

Rashes - Hives

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:39

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Antimon. crud. 15x, Apis mel. 15x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium maj. 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Histaminum hydrochloricum 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulex irr. 15x, Pulsatilla 15x, Rhus tox. 15x, Sarsaparilla 15x, Sulphur 15x, Echinacea 3x, Rumex crisp. 3x, Taraxacum 3x, Urtica ur. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with rashes and other allergic skin reactions such as burning, itching, redness, swelling and discomfort.

Uses

INDICATIONS & USAGE SECTION

Rashes - Hives Formulated for symptoms associated with rashes and other allergic skin reactions such as burning, itching, redness, swelling and discomfort.

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#

SS43-L01
SS43-L01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-8013-12020-01-31C16284748780-19d75b9d1-2aa8-f424-e053-dadaa90a57ceRashes - Hives

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-8013-1Rashes - Hives29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-8013RASHES - HIVES (ANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 1 package rows20140429_2c83e455-433e-e7ef-7a70-cb009ff3a185.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Antimony TrisulfideACTIVE INGREDIENTF79059A38U1
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Berberis Vulgaris Root BarkACTIVE INGREDIENT1TH8Q20J0U1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN1
Croton Tiglium SeedACTIVE INGREDIENT0HK2GZK66E1
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Giant PuffballACTIVE INGREDIENTI6839Y031A1
GraphiteACTIVE INGREDIENT4QQN74LH4O1
Histamine DihydrochlorideACTIVE INGREDIENT3POA0Q644U1
KeroseneACTIVE INGREDIENT1C89KKC04E1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT1
Pulex IrritansACTIVE INGREDIENTL63DD62R8R1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Rumex Crispus RootACTIVE INGREDIENT9N1RM2S62C1
Smilax Regelii RootACTIVE INGREDIENT2H1576D5WG1
Solanum Dulcamara TopACTIVE INGREDIENTKPS1B1162N1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
SulfurACTIVE INGREDIENT70FD1KFU701
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3751
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Urtica UrensACTIVE INGREDIENTIHN2NQ5OF91
Antimony TrisulfideACTIVE MOIETYF79059A38U1
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Berberis Vulgaris Root BarkACTIVE MOIETY1TH8Q20J0U1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Chelidonium MajusACTIVE MOIETY7E889U5RNN1
Croton Tiglium SeedACTIVE MOIETY0HK2GZK66E1
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Giant PuffballACTIVE MOIETYI6839Y031A1
GraphiteACTIVE MOIETY4QQN74LH4O1
HistamineACTIVE MOIETY820484N8I31
KeroseneACTIVE MOIETY1C89KKC04E1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT1
Pulex IrritansACTIVE MOIETYL63DD62R8R1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Rumex Crispus RootACTIVE MOIETY9N1RM2S62C1
Smilax Regelii RootACTIVE MOIETY2H1576D5WG1
Solanum Dulcamara TopACTIVE MOIETYKPS1B1162N1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
SulfurACTIVE MOIETY70FD1KFU701
Taraxacum OfficinaleACTIVE MOIETY39981FM3751
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Urtica UrensACTIVE MOIETYIHN2NQ5OF91
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-801355714-8013-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
Antimony TrisulfideF79059A38UACTIB
Apis Mellifera7S82P3R43ZACTIB
Arsenic TrioxideS7V92P67HOACTIM
Berberis Vulgaris Root Bark1TH8Q20J0UACTIB
Giant PuffballI6839Y031AACTIB
Bryonia Alba RootT7J046YI2BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Chelidonium Majus7E889U5RNNACTIB
Croton Tiglium Seed0HK2GZK66EACTIB
Solanum Dulcamara TopKPS1B1162NACTIB
Graphite4QQN74LH4OACTIB
Histamine Dihydrochloride3POA0Q644UACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Kerosene1C89KKC04EACTIB
Pulex IrritansL63DD62R8RACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Smilax Regelii Root2H1576D5WGACTIB
Sulfur70FD1KFU70ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Rumex Crispus Root9N1RM2S62CACTIB
Taraxacum Officinale39981FM375ACTIB
Urtica UrensIHN2NQ5OF9ACTIB
Alcohol3K9958V90MIACT

Complete SPL Sections#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Rashes - Hives Formulated for symptoms associated with rashes and other allergic skin reactions such as burning, itching, redness, swelling and discomfort.

DOSAGE & ADMINISTRATION SECTION

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.

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Antimon. crud. 15x, Apis mel. 15x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium maj. 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Histaminum hydrochloricum 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulex irr. 15x, Pulsatilla 15x, Rhus tox. 15x, Sarsaparilla 15x, Sulphur 15x, Echinacea 3x, Rumex crisp. 3x, Taraxacum 3x, Urtica ur. 3x.

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Formulated for symptoms associated with rashes and other allergic skin reactions such as burning, itching, redness, swelling and discomfort.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

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

WARNINGS SECTION

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML