Vitiligo description, usages, side effects, indications, overdosage, supplying and lots more!

Vitiligo

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
 Vitiligo

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 - 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%.  

QUESTIONS SECTION

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

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. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

Vitiligo

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

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2350
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 10 [hp_X]
BERBERIS VULGARIS ROOT BARK BERBERIS VULGARIS ROOT BARK 10 [hp_X]
GIANT PUFFBALL Giant Puffball 10 [hp_X]
MUCUNA PRURIENS FRUIT TRICHOME MUCUNA PRURIENS FRUIT TRICHOME 10 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 10 [hp_X]
Hura Crepitans Sap Hura Crepitans Sap 10 [hp_X]
CENTELLA ASIATICA 10 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 10 [hp_X]
Daphne Mezereum Bark Daphne Mezereum Bark 10 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 10 [hp_X]
RUMEX CRISPUS ROOT Rumex Crispus Root 10 [hp_X]
SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE 10 [hp_X]
TARAXACUM OFFICINALE Taraxacum Officinale 10 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X]
Urtica Urens URTICA URENS 10 [hp_X]
Iris Versicolor Root Iris Versicolor Root 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2350-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-2350-2 59.14 in 1 BOTTLE, GLASS
3 NDC:55714-2350-0 .5 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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