Muscle Ease

Manufacturer
SOMBRA COSMETICS INC.
Effective date
2026-07-01
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
weekly-update
Hydrated at
2026-07-17 21:42:21

Label at a glance#

ProductMUSCLE EASE
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure9 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with:  simple backaches, arthritis, strains, bruises, and sprains

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age : consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 3%

Camphor USP 3%

Purpose

OTC - PURPOSE SECTION

PURPOSE
EXTERNAL ANALGESIC



Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with:  simple backaches, arthritis, strains, bruises, and sprains

Warnings

WARNINGS SECTION

For external use only.  Do not use on wounds or damaged skin.  When using this product:  avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if:  condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe vera extract, capsaicin, carbomer, decyl polyglucose, water, grapefruit seed extract, green tea extract, orange peel extract, queen of the prairie extract, rose water, sodium  hydroxymethylglycinate, vegetable glycerin, witch hazel, yucca extract

Questions or Comments

OTC - QUESTIONS SECTION

1-800-225-3963

Muscle Ease 4oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Muscle Ease 4ozMuscle Ease 4oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-2301-22025-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22025-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42025-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42025-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22023-02-14C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22023-02-14C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42023-02-14C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42023-02-14C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22023-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22023-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42023-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42023-01-30C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22020-03-06C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22020-03-06C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42020-03-06C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42020-03-06C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22020-01-31C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-22020-01-31C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42020-01-31C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease
61577-2301-42020-01-31C16284748780-19d75b9d0-f931-f424-e053-dadaa90a57ceMuscle Ease

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET2
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET2
MENTHOLACTIVE MOIETYL7T10EIP3A2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
CAPSICUMINACTIVE INGREDIENT00UK7646FG2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E2
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6Y2
FILIPENDULA ULMARIA FLOWERINACTIVE INGREDIENT06L18L32G62
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GRAPEFRUIT SEED OILINACTIVE INGREDIENT598D944HOL2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
ORANGE PEELINACTIVE INGREDIENTTI9T76XD442
ROSA CENTIFOLIA FLOWER OILINACTIVE INGREDIENTH32V31VMWY2
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XT2
WATERINACTIVE INGREDIENT059QF0KO0R2
WITCH HAZELINACTIVE INGREDIENT101I4J0U342
YUCCA SCHIDIGERA ROOTINACTIVE INGREDIENTE2H9ET15AT2

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-230161577-2301-4, 61577-2301-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-05-29full-release2026-06-01 01:01:43

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ORANGE PEELORANGE PEELTI9T76XD44SYRUP / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ORANGE PEELORANGE PEELTI9T76XD44SYRUP / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
ORANGE PEELORANGE PEELTI9T76XD44SYRUP / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 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
MUSCLE EASEMENTHOL CAMPHORSOMBRA COSMETICS INC.03fff4bf-04ed-49a6-b40f-4d98c2b42f692026-07-01WarningsExact identifier
ndc (package): 61577-2301-2
ndc (package): 61577-2301-4
ndc (product): 61577-2301
ndc11 (package): 61577230102
ndc11 (package): 61577230104
spl id: 55928bab-8746-de18-e063-6394a90a7f64
spl set id: 03fff4bf-04ed-49a6-b40f-4d98c2b42f69

Reported adverse events (FAERS/openFDA)#

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