Hair - scalp

Hair - scalp
SPL v1
SPL
SPL Set ID 07fb9475-dd75-5425-d2bb-06a0b6344b71
Route
ORAL
Published
Effective Date 2012-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Apis Mellifera (15 [hp_X]) Arsenic Cation (3+) (3 [hp_X]) Oyster Shell Calcium Carbonate, Crude Solanum Dulcamara Top Graphite Calcium Sulfide Goldenseal Hydrofluoric Acid Carbonate Ion Lycopodium Clavatum Spore Daphne Mezereum Bark Nerium Oleander Leaf Kerosene Phosphoric Acid Phosphorus Toxicodendron Pubescens Leaf Selenium Sepia Officinalis Juice Silicon Dioxide Sulfur Thuja Occidentalis Leafy Twig
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Hair - Scalp   Formulated for symptoms associated with hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.

Purpose

Formulated for symptoms associated with hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.


Medication Information

Purpose

Formulated for symptoms associated with hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.

Description

Hair - Scalp   Formulated for symptoms associated with hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.

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 hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.

Inactive Ingredient Section

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

Indications & Usage Section

Hair - Scalp   Formulated for symptoms associated with hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.

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

Apis mel. 15x, Arsenicum alb. 15x, Calc.carb. 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrastis 15x, Hydrofluoricum acidum 15x, Kali carb. 15x, Lycopodium 15x, Mezereum 15x, Oleander 15x, Petroleum 15x, Phosphoricum ac. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Selenium 15x, Sepia 15x, Silicea 15x, Sulphur 15x, Hydrastis 3x,Thuja occ. 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 hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.

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)

Hair - Scalp   Formulated for symptoms associated with hair and scalp conditions such as dandruff, hair loss, premature graying, soreness and sensitivity.

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)

Apis mel. 15x, Arsenicum alb. 15x, Calc.carb. 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrastis 15x, Hydrofluoricum acidum 15x, Kali carb. 15x, Lycopodium 15x, Mezereum 15x, Oleander 15x, Petroleum 15x, Phosphoricum ac. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Selenium 15x, Sepia 15x, Silicea 15x, Sulphur 15x, Hydrastis 3x,Thuja occ. 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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