vitiligo

 vitiligo
SPL v2
SPL
SPL Set ID cba959cf-fcc0-ed50-5703-362188d57092
Route
ORAL
Published
Effective Date 2012-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (10 [hp_X]) Berberis Vulgaris Root Bark (3 [hp_X]) Giant Puffball Mucuna Pruriens Fruit Trichome Echinacea, Unspecified Hura Crepitans Sap Centella Asiatica Lycopodium Clavatum Spore Daphne Mezereum Bark Toxicodendron Pubescens Leaf Rumex Crispus Root Sepia Officinalis Juice Taraxacum Officinale Thuja Occidentalis Leafy Twig Urtica Urens Iris Versicolor Root
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Vitiligo    Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.

Purpose

Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.


Medication Information

Purpose

Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.

Description

Vitiligo    Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.

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 pigmentation loss, changes in the skin, inflammation, itching and premature graying.

Inactive Ingredient Section

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

Indications & Usage Section

Vitiligo    Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.

Dosage & Administration Section

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

Otc Active Ingredient Section

Arsenicum alb. 10x, Berber. vulg. 10x, Bovista 10x, Dolichos 10x, Echinacea 10x, Hura brasiliensis 10x, Hydrocotyle 10x, Lycopodium 10x, Mezereum 10x, Rhus toxicodendron 10x, Rumex crisp. 10x, Sepia 10x, Taraxacum 10x, Thuja occ. 10x, Urtica ur. 10x, Echinacea 3x, Iris versicolor 3x, Rumex crisp. 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 pigmentation loss, changes in the skin, inflammation, itching and premature graying.

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)

Vitiligo    Formulated for symptoms associated with pigmentation loss, changes in the skin, inflammation, itching and premature graying.

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) one to four times daily 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)

Arsenicum alb. 10x, Berber. vulg. 10x, Bovista 10x, Dolichos 10x, Echinacea 10x, Hura brasiliensis 10x, Hydrocotyle 10x, Lycopodium 10x, Mezereum 10x, Rhus toxicodendron 10x, Rumex crisp. 10x, Sepia 10x, Taraxacum 10x, Thuja occ. 10x, Urtica ur. 10x, Echinacea 3x, Iris versicolor 3x, Rumex crisp. 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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