Cold Sores

Cold Sores
SPL v2
SPL
SPL Set ID f7579a33-7523-53bc-9980-4bd62d277e89
Route
ORAL
Published
Effective Date 2012-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (10 [hp_X]) Bryonia Alba Root (3 [hp_X]) Lytta Vesicatoria Chelidonium Majus Helianthemum Canadense Conium Maculatum Flowering Top Croton Tiglium Seed Solanum Dulcamara Top Graphite Dichromate Ion Lycopodium Clavatum Spore Daphne Mezereum Bark Strychnos Nux-vomica Seed Kerosene Pulsatilla Vulgaris Ranunculus Bulbosus Toxicodendron Pubescens Leaf Smilax Regelii Root Sepia Officinalis Juice Sulfur Thuja Occidentalis Leafy Twig Echinacea, Unspecified Hypericum Perforatum
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Cold Sores  Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.

Purpose

Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.


Medication Information

Purpose

Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.

Description

Cold Sores  Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.

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, GA30012

Questions?  1.800.448.7256 

Otc Purpose Section

Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.

Inactive Ingredient Section

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

Indications & Usage Section

Cold Sores  Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.

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

Arsenicum alb. 10x, Bryonia 10x, Cantharis 10x, Chelidonium majus 10x, Cistus canadensis 10x, Conium 10x, Croton 10x, Dulcamara 10x, Graphites 10x, Kali bic.10x, Lycopodium 10x, Mezereum 10x, Nux vom. 10x, Petroleum 10x, Pulsatilla 10x, Ranunc. bulb. 10x, Rhus toxicodendron 10x, Sarsaparilla 10x, Sepia 10x, Sulphur 10x, Thuja occ. 10x, Echinacea 3x, Hypericum 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, GA30012

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.

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)

Cold Sores  Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.

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)

Arsenicum alb. 10x, Bryonia 10x, Cantharis 10x, Chelidonium majus 10x, Cistus canadensis 10x, Conium 10x, Croton 10x, Dulcamara 10x, Graphites 10x, Kali bic.10x, Lycopodium 10x, Mezereum 10x, Nux vom. 10x, Petroleum 10x, Pulsatilla 10x, Ranunc. bulb. 10x, Rhus toxicodendron 10x, Sarsaparilla 10x, Sepia 10x, Sulphur 10x, Thuja occ. 10x, Echinacea 3x, Hypericum 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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