Vitiligo 2592l

Vitiligo 2592l
SPL v1
SPL
SPL Set ID 136945e2-6f2a-a0df-e063-6294a90a994b
Route
ORAL
Published
Effective Date 2024-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea, Unspecified (15 [hp_X]) Hura Crepitans Sap (6 [hp_X]) 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 Arsenic Cation (3+) Berberis Vulgaris Root Bark Iris Versicolor Root Lycoperdon Utriforme Fruiting Body Mucuna Pruriens Fruit Trichome
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-03-11

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

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

Inactive Ingredient Section

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

Indications & Usage Section

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

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Iris versicolor 6x, Rumex crispus 6x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Dolichos 15x, Echinacea 15x, Hura bras. 15x, Hydrocotyle 15x, Lycopodium 15x, Mezereum 15x, Rhus tox 15x, Rumex crisp. 15x, Sepia 15x, Taraxacum 15x, Thuja occ. 15x, Urtica ur. 15x.

Otc Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a doctor before use.

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)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as loss of pigmentation, 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 alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Iris versicolor 6x, Rumex crispus 6x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Dolichos 15x, Echinacea 15x, Hura bras. 15x, Hydrocotyle 15x, Lycopodium 15x, Mezereum 15x, Rhus tox 15x, Rumex crisp. 15x, Sepia 15x, Taraxacum 15x, Thuja occ. 15x, Urtica ur. 15x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding, ask a doctor before use.

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

All Sections (JSON)