FDA.reportPublic FDA data

Muscle Ease

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:46

Label at a glance#

ProductMuscle Ease
Active ingredientAconitum Napellus, Antimony Potassium Tartrate, Silver Nitrate, Arnica Montana, Bryonia Alba Root, Matricaria Recutita, Chelidonium Majus, Black Cohosh, Eupatorium Perfoliatum Flowering Top, Hypericum Perforatum, Strychnos Nux-vomica Seed, Toxicodendron Pubescens Leaf, Ruta Graveolens Flowering Top, Lactic Acid, L-, Datura Stramonium, Strychnine, Phytolacca Americana Root, Comfrey Root
Label structure10 sections

Label contents#

Full prescribing information#

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

OTC - 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.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2272-12020-01-31C16284748780-19d75b9d0-dca5-f424-e053-dadaa90a57ceMuscle Ease
55714-2272-22020-01-31C16284748780-19d75b9d0-dca5-f424-e053-dadaa90a57ceMuscle Ease

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2272-1Muscle Ease29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-2272-2Muscle Ease59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2272MUSCLE 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.]1Legacy NDC, 2 package rows20120509_77b37cb6-9196-c3df-b91a-09dfaf2e81d5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Antimony Potassium TartrateACTIVE INGREDIENTDL6OZ476V31
Arnica MontanaACTIVE INGREDIENTO80TY208ZW1
Black CohoshACTIVE INGREDIENTK73E24S6X91
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN1
Comfrey RootACTIVE INGREDIENTM9VVZ08EKQ1
Datura StramoniumACTIVE INGREDIENTG6W4F0V8Z31
Eupatorium Perfoliatum Flowering TopACTIVE INGREDIENT1W0775VX6E1
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB1
Lactic Acid, L-ACTIVE INGREDIENTF9S9FFU82N1
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
Phytolacca Americana RootACTIVE INGREDIENT11E6VI8VEG1
Ruta Graveolens Flowering TopACTIVE INGREDIENTN94C2U587S1
Silver NitrateACTIVE INGREDIENT95IT3W8JZE1
StrychnineACTIVE INGREDIENTH9Y79VD43J1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
AntimonyACTIVE MOIETY9IT35J3UV31
Arnica MontanaACTIVE MOIETYO80TY208ZW1
Black CohoshACTIVE MOIETYK73E24S6X91
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Chelidonium MajusACTIVE MOIETY7E889U5RNN1
Comfrey RootACTIVE MOIETYM9VVZ08EKQ1
Datura StramoniumACTIVE MOIETYG6W4F0V8Z31
Eupatorium Perfoliatum Flowering TopACTIVE MOIETY1W0775VX6E1
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB1
Lactic Acid, L-ACTIVE MOIETYF9S9FFU82N1
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
Phytolacca Americana RootACTIVE MOIETY11E6VI8VEG1
Ruta Graveolens Flowering TopACTIVE MOIETYN94C2U587S1
Silver CationACTIVE MOIETY57N7B0K90A1
StrychnineACTIVE MOIETYH9Y79VD43J1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-227255714-2272-1, 55714-2272-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
Aconitum NapellusU0NQ8555JDACTIB
Antimony Potassium TartrateDL6OZ476V3ACTIB
Silver Nitrate95IT3W8JZEACTIB
Arnica MontanaO80TY208ZWACTIB
Bryonia Alba RootT7J046YI2BACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Chelidonium Majus7E889U5RNNACTIB
Black CohoshK73E24S6X9ACTIB
Eupatorium Perfoliatum Flowering Top1W0775VX6EACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Ruta Graveolens Flowering TopN94C2U587SACTIB
Lactic Acid, L-F9S9FFU82NACTIB
Datura StramoniumG6W4F0V8Z3ACTIB
StrychnineH9Y79VD43JACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Phytolacca Americana Root11E6VI8VEGACTIB
Ruta Graveolens Flowering TopN94C2U587SACTIB
Comfrey RootM9VVZ08EKQACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
90041aed-d378-6ea0-0b3c-7753ba04562377b37cb6-9196-c3df-b91a-09dfaf2e81d52011-03-01WarningsExact identifier
spl id: 90041aed-d378-6ea0-0b3c-7753ba045623
spl set id: 77b37cb6-9196-c3df-b91a-09dfaf2e81d5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.