MUSCLE EASE - aconitum nap., antimon. tart.,arg. nit., arnica, bryonia, chamomilla,chelidonium majus, cimicifuga, eupatorium perf.,hypericum, nux vom., rhus toxicodendron, ruta,sarcolacticum ac., stramonium, strychninum,chamomilla, phytolacca, ruta, symphytum. 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.

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Muscle Ease

INDICATIONS & USAGE SECTION

Muscle Ease  Formulated for symptoms associated with muscle discomfort such as bruising, pain, soreness, stiffness, spasms and weakness.

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

Aconitum nap. 15x, Antimon. tart. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Chamomilla 15x, Chelidonium majus 15x, Cimicifuga 15x, Eupatorium perf. 15x, Hypericum 15x, Nux vom. 15x, Rhus toxicodendron 15x, Ruta 15x,Sarcolacticum ac. 15x, Stramonium 15x, Strychninum 15x, Chamomilla 3x, Phytolacca 3x, Ruta 3x, Symphytum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with muscle discomfort such as bruising, pain, soreness, stiffness, spasms and weakness.

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, 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

package label

MUSCLE EASE  
aconitum nap., antimon. tart.,arg. nit., arnica, bryonia, chamomilla,chelidonium majus, cimicifuga, eupatorium perf.,hypericum, nux vom., rhus toxicodendron, ruta,sarcolacticum ac., stramonium, strychninum,chamomilla, phytolacca, ruta, symphytum. liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2272
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus15 [hp_X]  in 1 mL
Antimony Potassium Tartrate (UNII: DL6OZ476V3) (Antimony - UNII:9IT35J3UV3) Antimony Potassium Tartrate15 [hp_X]  in 1 mL
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 mL
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita15 [hp_X]  in 1 mL
Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mL
Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh15 [hp_X]  in 1 mL
Eupatorium Perfoliatum Flowering Top (UNII: 1W0775VX6E) (Eupatorium Perfoliatum Flowering Top - UNII:1W0775VX6E) Eupatorium Perfoliatum Flowering Top15 [hp_X]  in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top15 [hp_X]  in 1 mL
Lactic Acid, L- (UNII: F9S9FFU82N) (Lactic Acid, L- - UNII:F9S9FFU82N) Lactic Acid, L-15 [hp_X]  in 1 mL
Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium15 [hp_X]  in 1 mL
Strychnine (UNII: H9Y79VD43J) (Strychnine - UNII:H9Y79VD43J) Strychnine15 [hp_X]  in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita3 [hp_X]  in 1 mL
Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG) Phytolacca Americana Root3 [hp_X]  in 1 mL
Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top3 [hp_X]  in 1 mL
Comfrey Root (UNII: M9VVZ08EKQ) (Comfrey Root - UNII:M9VVZ08EKQ) Comfrey Root3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2272-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2272-259.14 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, API MANUFACTURE

Revised: 3/2011
Document Id: 90041aed-d378-6ea0-0b3c-7753ba045623
Set id: 77b37cb6-9196-c3df-b91a-09dfaf2e81d5
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.