Acne

Acne
SPL v1
SPL
SPL Set ID 72ad36a2-5476-b0a4-caae-1b86d92dabd8
Route
ORAL
Published
Effective Date 2012-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Antimony Trisulfide (15 [hp_X]) Arsenic Cation (3+) (3 [hp_X]) Gold Mahonia Aquifolium Root Bark Giant Puffball Activated Charcoal Causticum Chelidonium Majus Solanum Dulcamara Top Graphite Calcium Sulfide Centella Asiatica Potassium Cation Iodide Ion Ledum Palustre Twig Lycopodium Clavatum Spore Strychnos Nux-vomica Seed Silicon Dioxide Sulfur Iodide Zinc Echinacea, Unspecified English Walnut Arctium Lappa Root Taraxacum Officinale
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Acne    Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

Purpose

Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.


Medication Information

Purpose

Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

Description

Acne    Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

Questions

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

Questions?  1.800.448.7256

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.  

Otc Purpose Section

Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

Inactive Ingredient Section

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

Indications & Usage section

Acne    Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

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

Antimon. crud. 15x, Arsenicum alb. 15x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium majus 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrocotyle 15x, Kali brom. 15x, Kali iod. 15x, Ledum 15x, Lycopodium 15x, Nux vom. 15x, Silicea 15x,Sulphur iod. 15x, Zinc. met. 15x, Echinacea 3x, Juglans regia 3x, Lappa 3x, Taraxacum 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

Questions (QUESTIONS)

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

Questions?  1.800.448.7256

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.  

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

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)

Acne    Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

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)

Antimon. crud. 15x, Arsenicum alb. 15x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium majus 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrocotyle 15x, Kali brom. 15x, Kali iod. 15x, Ledum 15x, Lycopodium 15x, Nux vom. 15x, Silicea 15x,Sulphur iod. 15x, Zinc. met. 15x, Echinacea 3x, Juglans regia 3x, Lappa 3x, Taraxacum 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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