Rosacea

Rosacea
SPL v1
SPL
SPL Set ID 65ad0ed2-a7f6-09ff-3aeb-ea707811868c
Route
ORAL
Published
Effective Date 2012-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (10 [hp_X]) Carbo Animalis (3 [hp_X]) Causticum Centella Asiatica Potassium Cation Iodide Ion Wood Creosote Lycopodium Clavatum Spore Strychnos Nux-vomica Seed Kerosene Toxicodendron Pubescens Leaf Sepia Officinalis Juice Sulfur Echinacea, Unspecified Taraxacum Officinale
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Rosacea  Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp .

Purpose

Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp.


Medication Information

Purpose

Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp.

Description

Rosacea  Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp .

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 associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp.

Inactive Ingredient Section

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

Indications & Usage Section

Rosacea  Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp .

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, Arsenicum bromatum 10x, Carbo animalis 10x, Causticum 10x, Hydrocotyle 10x, Kali brom. 10x, Kali iod. 10x, Kreosotum 10x, Lycopodium 10x, Nux vom. 10x, Petroleum 10x, Rhus toxicodendron 10x, Sepia 10x, Sulphur 10x, Echinacea 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

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 associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Rosacea  Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp .

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, Arsenicum bromatum 10x, Carbo animalis 10x, Causticum 10x, Hydrocotyle 10x, Kali brom. 10x, Kali iod. 10x, Kreosotum 10x, Lycopodium 10x, Nux vom. 10x, Petroleum 10x, Rhus toxicodendron 10x, Sepia 10x, Sulphur 10x, Echinacea 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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