FDA.reportPublic FDA data

Professional Therapy MuscleCare Pro

Manufacturer
ACTIVE AND INNOVATIVE, LLC | MCKENNA LABS, INC.
Effective date
2024-04-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:11:51

Label at a glance#

ProductProfessional Therapy MuscleCare Pro Roll-on
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age or older: Using the roll-on apllicator massage a liberal amount of gel directly on the affected area not more than 3 to 4 times daily. Children under the age of 12: Do not use, consult a doctor.

Storage and handling

Store under normal storage conditions. Store away from children.

Label contents#

Full prescribing information#

Active Ingredietns (% by weight) Purpose

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Analgesic Pain Relief

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

For external use only.

  • Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or on mucous membranes.
  • If condition worsens, or if symptoms persist for more than 7 days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin. Do not bandage tightly.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Use only as directed
  • Do not use if pregnant or breastfeeding
  • If swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age or older: Using the roll-on apllicator massage a liberal amount of gel directly on the affected area not more than 3 to 4 times daily. Children under the age of 12: Do not use, consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store under normal storage conditions. Store away from children.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Aminomethyl Propanol, Boswellia Serrata Resin Extract, Chondroitin Sulfate, D-Glucosamine Sulfate
Potassium, Dimethyl Sulfone (MSM), Eucalyptus Globulus Leaf/Twig Oil, Glycerin, Ilex Paraguariensis Leaf Extract, Magnesium
Chloride, Mentha Piperita (Peppermint) Oil, Propylene Glycol, SD Alcohol 40-B, Water, Zea Mays (Corn) Starch

Professionl Therapy MuscleCare Maximum Strength Pain Relieving Gel Roll-on

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039731camphor 4 % / menthol 10 % Topical GelPSN4
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCD4
1039731camphor 4 % / menthol 10 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70039-301-03Professional Therapy MuscleCare ProRoll-on85 g in 1 BOTTLE, WITH APPLICATORGEL854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70039-301PROFESSIONAL THERAPY MUSCLECARE PRO ROLL-ON (CAMPHOR, MENTHOL) GEL [ACTIVE AND INNOVATIVE, LLC]4Current NDC, 1 package rows20240502_1755ec89-c404-1c17-e063-6394a90ab9fb.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70039-30170039-301-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
STARCH, CORNO8232NY3SJIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
GLYCERINPDC6A3C0OXIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE15VQ11I66NIACT
WATER059QF0KO0RIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
MENTHA PIPERITA79M2M2UDA9IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Professional Therapy MuscleCare Pro Roll-onCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1755ec89-c404-1c17-e063-6394a90ab9fb2024-04-30WarningsExact identifier
ndc (package): 70039-301-03
ndc (product): 70039-301
ndc11 (package): 70039030103
spl id: 1755ec89-c403-1c17-e063-6394a90ab9fb
spl set id: 1755ec89-c404-1c17-e063-6394a90ab9fb

Reported adverse events (FAERS/openFDA)#

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