ACTIVE AND INNOVATIVE (as PLD) - MUSCLECARE COLD GEL (70039-302)

Manufacturer
ACTIVE AND INNOVATIVE, LLC | MCKENNA LABS, INC.
Effective date
2024-05-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:11:56

Label at a glance#

ProductProfessional Therapy MuscleCare Pro Pain Relieving Cold Gel
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: 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)

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.

  • Catution: 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 or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Do not apply to wounds or damaged skin. Do not bandage tighlty.

Keep out of reach of children. Flammable: Keep away from fire and flame.

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: 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 by Dr. Chris Oswald

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ArtworkArtwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039731camphor 4 % / menthol 10 % Topical GelPSN5
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCD5
1039731camphor 4 % / menthol 10 % Topical GelSY5

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
70039-302-16Professional Therapy MuscleCare ProPain Relieving Cold Gel453 g in 1 BOTTLE, PUMPGEL4535
70039-302-32Professional Therapy MuscleCare ProPain Relieving Cold Gel906 g in 1 BOTTLE, PUMPGEL9065

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70039-302PROFESSIONAL THERAPY MUSCLECARE PRO PAIN RELIEVING COLD GEL (CAMPHOR, MENTHOL) GEL [ACTIVE AND INNOVATIVE, LLC]5Current NDC, 2 package rows20240504_1794c512-5f42-4ec3-e063-6394a90a87cd.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
70039-30270039-302-32, 70039-302-16

Ingredients#

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

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

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 Pain Relieving Cold GelCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1794c512-5f42-4ec3-e063-6394a90a87cd2024-05-03WarningsExact identifier
ndc (package): 70039-302-16
ndc (package): 70039-302-32
ndc (product): 70039-302
ndc11 (package): 70039030216
ndc11 (package): 70039030232
spl id: 1794c494-425d-3eee-e063-6394a90aa08d
spl set id: 1794c512-5f42-4ec3-e063-6394a90a87cd

Reported adverse events (FAERS/openFDA)#

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