Coldso 2408l

Coldso 2408l
SPL v2
SPL
SPL Set ID 9b952b77-d172-1828-e053-2a95a90ab4f6
Route
ORAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (15 [hp_X]) Bryonia Alba Root (6 [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 Anemone Pulsatilla Ranunculus Bulbosus Toxicodendron Pubescens Leaf Smilax Ornata Root Sepia Officinalis Juice Sulfur Thuja Occidentalis Leafy Twig Echinacea, Unspecified Hypericum Perforatum
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

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

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

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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 alcohol 20%.

Indications & Usage Section

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

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Hypericum 6x, Arsenicum alb. 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Cistus canadensis 15x, Conium 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Kali bic.15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulsatilla 15x, Ranunc. bulb. 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sepia 15x, Sulphur 15x, Thuja occ. 15x.

Otc Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a doctor before use.

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)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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 alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Hypericum 6x, Arsenicum alb. 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Cistus canadensis 15x, Conium 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Kali bic.15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulsatilla 15x, Ranunc. bulb. 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sepia 15x, Sulphur 15x, Thuja occ. 15x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding, ask a doctor before use.

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

All Sections (JSON)