COLD SORES - arsenic trioxide, bryonia alba root, lytta vesicatoria, chelidonium majus, helianthemum canadense, conium maculatum flowering top, croton tiglium seed, solanum dulcamara top, graphite, potassium dichromate, 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 and hypericum perforatum liquid 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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 - 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%.  

QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA30012
Questions?  1.800.448.7256 

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 - 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.

PACKAGE LABEL

package label

COLD SORES  
arsenicum alb., bryonia, cantharis, chelidonium majus, cistus canadensis, conium, croton, dulcamara, graphites, kali bic., lycopodium, mezereum, nux vom., petroleum, pulsatilla, ranunc. bulb., rhus toxicodendron, sarsaparilla, sepia, sulphur, thuja occ., echinacea, hypericum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2276
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide10 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root10 [hp_X]  in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria) Lytta Vesicatoria10 [hp_X]  in 1 mL
Chelidonium Majus (Chelidonium Majus) Chelidonium Majus10 [hp_X]  in 1 mL
Helianthemum Canadense (Helianthemum Canadense) Helianthemum Canadense10 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (Conium Maculatum Flowering Top) Conium Maculatum Flowering Top10 [hp_X]  in 1 mL
Croton Tiglium Seed (Croton Tiglium Seed) Croton Tiglium Seed10 [hp_X]  in 1 mL
Solanum Dulcamara Top (Solanum Dulcamara Top) Solanum Dulcamara Top10 [hp_X]  in 1 mL
Graphite (Graphite) Graphite10 [hp_X]  in 1 mL
Potassium Dichromate (Dichromate Ion) Potassium Dichromate10 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
Daphne Mezereum Bark (Daphne Mezereum Bark) Daphne Mezereum Bark10 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed10 [hp_X]  in 1 mL
Kerosene (Kerosene) Kerosene10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Ranunculus Bulbosus (Ranunculus Bulbosus) Ranunculus Bulbosus10 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 mL
Smilax Regelii Root (Smilax Regelii Root) Smilax Regelii Root10 [hp_X]  in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice) Sepia Officinalis Juice10 [hp_X]  in 1 mL
Sulfur (Sulfur) Sulfur10 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig) Thuja Occidentalis Leafy Twig10 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Hypericum Perforatum (Hypericum Perforatum) Hypericum Perforatum3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-2276-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2276-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2276-0.5 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2276), API MANUFACTURE(55714-2276)

Revised: 03/2011
Document Id: ae3ea2bd-ae7b-6b4a-cb75-030cdd371467
Set id: f7579a33-7523-53bc-9980-4bd62d277e89
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.