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 pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-2277-0, 55714-2277-1, 55714-2277-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
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 pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2277 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 10 [hp_X] in 1 g Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 10 [hp_X] in 1 g Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria 10 [hp_X] in 1 g Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus 10 [hp_X] in 1 g Helianthemum Canadense (UNII: 46G3W789Q3) (Helianthemum Canadense - UNII:46G3W789Q3) Helianthemum Canadense 10 [hp_X] in 1 g Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top 10 [hp_X] in 1 g Croton Tiglium Seed (UNII: 0HK2GZK66E) (Croton Tiglium Seed - UNII:0HK2GZK66E) Croton Tiglium Seed 10 [hp_X] in 1 g Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top 10 [hp_X] in 1 g Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite 10 [hp_X] in 1 g Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate 10 [hp_X] in 1 g Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 10 [hp_X] in 1 g Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark 10 [hp_X] in 1 g Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 10 [hp_X] in 1 g Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene 10 [hp_X] in 1 g Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 10 [hp_X] in 1 g Ranunculus Bulbosus (UNII: AEQ8NXJ0MB) (Ranunculus Bulbosus - UNII:AEQ8NXJ0MB) Ranunculus Bulbosus 10 [hp_X] in 1 g Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 10 [hp_X] in 1 g Smilax Regelii Root (UNII: 2H1576D5WG) (Smilax Regelii Root - UNII:2H1576D5WG) Smilax Regelii Root 10 [hp_X] in 1 g Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 10 [hp_X] in 1 g Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 10 [hp_X] in 1 g Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397) Thuja Occidentalis Leafy Twig 10 [hp_X] in 1 g Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 g Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength Sucrose (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2277-1 28.35 g in 1 BOTTLE, GLASS 2 NDC:55714-2277-2 56.7 g in 1 BOTTLE, GLASS 3 NDC:55714-2277-0 7.08 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2277)