Cold Sores by Newton Laboratories, Inc. ColdSo 2409P-Dis

Cold Sores by

Drug Labeling and Warnings

Cold Sores by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 
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.

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ColdSo 2409P-Dis

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

OTC - PURPOSE SECTION

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

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 tox. 15x, Sarsaparilla 15x, Sepia 15x, Sulphur 15x, Thuja occ. 15x.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

INDICATIONS & USAGE SECTION

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

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 pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55714-2409
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	15 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X]  in 1 g
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	15 [hp_X]  in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	15 [hp_X]  in 1 g
HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3)	HELIANTHEMUM CANADENSE	15 [hp_X]  in 1 g
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	15 [hp_X]  in 1 g
CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E)	CROTON TIGLIUM SEED	15 [hp_X]  in 1 g
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	15 [hp_X]  in 1 g
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	15 [hp_X]  in 1 g
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	15 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [hp_X]  in 1 g
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV)	DAPHNE MEZEREUM BARK	15 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X]  in 1 g
KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E)	KEROSENE	15 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	15 [hp_X]  in 1 g
RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB)	RANUNCULUS BULBOSUS	15 [hp_X]  in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	15 [hp_X]  in 1 g
SMILAX ORNATA WHOLE (UNII: SJO6NF5H81) (SMILAX ORNATA WHOLE - UNII:SJO6NF5H81)	SMILAX ORNATA WHOLE	15 [hp_X]  in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	15 [hp_X]  in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	15 [hp_X]  in 1 g
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	15 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [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: 55714-2409-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/07/2018	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/07/2018	01/01/2020

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-2409)

Revised: 2/2020

Document Id: 9defb73d-f54e-c204-e053-2a95a90ae2e4

34390-5

Set id: 7c765d76-5bd7-2748-e053-2991aa0a4a11

Version: 2

Effective Time: 20200206

 

Newton Laboratories, Inc.