Poison Ivy

Poison Ivy
SPL v2
SPL
SPL Set ID 7cf721fe-8442-5939-33d0-1bd969e70a8b
Route
ORAL
Published
Effective Date 2012-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Xerophyllum Asphodeloides (30 [hp_X]) Aconitum Napellus (15 [hp_X]) Semecarpus Anacardium Juice (3 [hp_X]) Apis Mellifera Bryonia Alba Root Lytta Vesicatoria Croton Tiglium Seed Graphite Grindelia Hirsutula Flowering Top Daphne Mezereum Bark Strychnos Nux-vomica Seed Ranunculus Bulbosus 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 2011-03-01

Description

Poison Ivy  Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

Purpose

Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.


Medication Information

Purpose

Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

Description

Poison Ivy  Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

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 poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

Inactive Ingredient Section

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

Indications & Usage Section

Poison Ivy  Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.   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

Xerophyllum asphodeloides 30x, Aconitum nap. 15x, Anacardium orientale 15x, Apis mel. 15x, Bryonia 15x, Cantharis 15x, Croton 15x, Graphites 15x, Grindelia 15x, Mezereum 15x, Nux vom. 15x, Ranunc. bulb. 15x, Rhus toxicodendron 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 poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

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)

Poison Ivy  Formulated for symptoms associated with poison ivy, oak and sumac such as itching, burning, pain, swelling and blistering.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY - SHAKE WELL.   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)

Xerophyllum asphodeloides 30x, Aconitum nap. 15x, Anacardium orientale 15x, Apis mel. 15x, Bryonia 15x, Cantharis 15x, Croton 15x, Graphites 15x, Grindelia 15x, Mezereum 15x, Nux vom. 15x, Ranunc. bulb. 15x, Rhus toxicodendron 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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