FDA.reportPublic FDA data

CAREALL Muscle Rub

Manufacturer
New World Imports, Inc
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:18:59

Label at a glance#

ProductCAREALL Muscle Rub Ultra Strength
Active ingredientLEVOMENTHOL, METHYL SALICYLATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol

Methyl Salicylate

OTC - PURPOSE SECTION

Topical analgesic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center Immediately.

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

WARNINGS SECTION

For external use only

Do not use:

On wounds or damaged skin

With a heating pad

On a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if

you have redness over the affected area

When using this product

Avoid contact with eyes

Do not bandage tightly

Stop use and ask a doctor if

Condition worsens or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

DOSAGE & ADMINISTRATION SECTION

Adults 12 years of age and older:

apply to affected area not more than 3 to 4 times daily

wash hands with soap and water after apply

Children under 12 years of age:ask a doctor

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride Solution, Citric Acid Monohydrate, Glyceryl Monostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lanolin, Polysorbate 80, Propylene Glycol, Purified Water (Aqua), Stearic Acid, Potassium Hydroxide, Xanthan Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Muscle RubMuscle Rub

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN5
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD5
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY5
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-105-03CAREALL Muscle RubUltra Strength85 g in 1 TUBECREAM855

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-105-03GM - Gram51824-105992b78a7-1bbe-4acb-af5c-88ec94b8104812024-11-05

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51824-10551824-105-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
LANOLIN7EV65EAW6HIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
XANTHAN GUMTTV12P4NEEIACT
LEVOMENTHOLBZ1R15MTK7ACTIB
METHYL SALICYLATELAV5U5022YACTIB

Source Document#

Source XML

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrthrexoDICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATEV2 Pharma, LLCeb070904-4f6f-42c0-981d-8dc8500401852026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 51824-105-03
ndc11 (package): 51824010503
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Incd066002d-8ceb-4d16-9744-d5ca25d2ad5a2025-12-01WarningsExact identifier
ndc (package): 51824-105-03
ndc (product): 51824-105
ndc11 (package): 51824010503
spl id: 44ebe505-1cdd-88cf-e063-6394a90a4baf
spl set id: d066002d-8ceb-4d16-9744-d5ca25d2ad5a
OrthaphenDICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATEV2 Pharma, LLC1583e691-5823-4a68-aafc-bf80b88542332025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 51824-105-03
ndc11 (package): 51824010503
FenovarDICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATEV2 Pharma, LLCcca25bd7-2afd-4ff1-adb3-0a77dfcd43422024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 51824-105-03
ndc11 (package): 51824010503

Reported adverse events (FAERS/openFDA)#

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