Rashes - Hives

Rashes - Hives
SPL v1
SPL
SPL Set ID 2c83e455-433e-e7ef-7a70-cb009ff3a185
Route
ORAL
Published
Effective Date 2012-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Antimony Trisulfide (15 [hp_X]) Apis Mellifera (3 [hp_X]) Arsenic Cation (3+) Berberis Vulgaris Root Bark Giant Puffball Bryonia Alba Root Lytta Vesicatoria Chelidonium Majus Croton Tiglium Seed Solanum Dulcamara Top Graphite Histamine Lycopodium Clavatum Spore Daphne Mezereum Bark Strychnos Nux-vomica Seed Kerosene Pulex Irritans Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Smilax Regelii Root Sulfur Echinacea, Unspecified Rumex Crispus Root Taraxacum Officinale Urtica Urens
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-04-15

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

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.  

Questions Section

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

Questions?  1.800.448.7256

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

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

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

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 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.


Structured Label Content

Package Label (PACKAGE LABEL)

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.  

Questions Section (QUESTIONS SECTION)

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

Questions?  1.800.448.7256

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%.

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 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.


Advanced Ingredient Data


Raw Label Data

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