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Rosacea

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Rosacea


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Rosacea  Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp .

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Arsenicum alb. 10x, Arsenicum bromatum 10x, Carbo animalis 10x, Causticum 10x, Hydrocotyle 10x, Kali brom. 10x, Kali iod. 10x, Kreosotum 10x, Lycopodium 10x, Nux vom. 10x, Petroleum 10x, Rhus toxicodendron 10x, Sepia 10x, Sulphur 10x, Echinacea 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp.

INACTIVE INGREDIENT SECTION

Gluten-free, non-GMO, beet-derived sucrose pellets.  

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
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

Rosacea

Arsenicum alb., Arsenicum bromatum, Carbo animalis, Causticum, Hydrocotyle, Kali brom., Kali iod., Kreosotum, Lycopodium, Nux vom., Petroleum, Rhus toxicodendron, Sepia, Sulphur, Echinacea, Taraxacum PELLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2325
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 10 [hp_X]
ARSENIC TRIBROMIDE Arsenic Cation (3+) 10 [hp_X]
CARBO ANIMALIS CARBO ANIMALIS 10 [hp_X]
CAUSTICUM CAUSTICUM 10 [hp_X]
CENTELLA ASIATICA 10 [hp_X]
POTASSIUM BROMIDE POTASSIUM CATION 10 [hp_X]
Potassium Iodide IODIDE ION 10 [hp_X]
WOOD CREOSOTE WOOD CREOSOTE 10 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 10 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 10 [hp_X]
KEROSENE KEROSENE 10 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 10 [hp_X]
SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE 10 [hp_X]
SULFUR SULFUR 10 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
TARAXACUM OFFICINALE Taraxacum Officinale 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2325-1 28.35 in 1 BOTTLE, GLASS
2 NDC:55714-2325-2 56.7 in 1 BOTTLE, GLASS
3 NDC:55714-2325-0 7.08 in 1 BOTTLE, GLASS

Marketing Information

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


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