Cold Sores description, usages, side effects, indications, overdosage, supplying and lots more!

Cold Sores

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Cold Sores

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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 Type Human otc drug label Item Code (Source) NDC:55714-2276
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 10 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 10 [hp_X]
LYTTA VESICATORIA LYTTA VESICATORIA 10 [hp_X]
CHELIDONIUM MAJUS CHELIDONIUM MAJUS 10 [hp_X]
Helianthemum Canadense Helianthemum Canadense 10 [hp_X]
Conium Maculatum Flowering Top CONIUM MACULATUM FLOWERING TOP 10 [hp_X]
Croton Tiglium Seed Croton Tiglium Seed 10 [hp_X]
Solanum Dulcamara Top Solanum Dulcamara Top 10 [hp_X]
Graphite GRAPHITE 10 [hp_X]
POTASSIUM DICHROMATE DICHROMATE ION 10 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 10 [hp_X]
Daphne Mezereum Bark Daphne Mezereum Bark 10 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 10 [hp_X]
KEROSENE KEROSENE 10 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 10 [hp_X]
Ranunculus Bulbosus Ranunculus Bulbosus 10 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 10 [hp_X]
SMILAX REGELII ROOT Smilax Regelii Root 10 [hp_X]
SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE 10 [hp_X]
SULFUR SULFUR 10 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2276-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-2276-2 59.14 in 1 BOTTLE, GLASS
3 NDC:55714-2276-0 .5 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.