ACTIVE AND INNOVATIVE (as PLD) - MUSCLECARE OINTMENT (70039-303)

Manufacturer
ACTIVE AND INNOVATIVE, LLC | MCKENNA LABS, INC.
Effective date
2024-05-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:56

Label at a glance#

ProductProfessional Therapy MuscleCare Pro
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: Rub this soothing cream 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 Ingredient (% by weight)

OTC - ACTIVE INGREDIENT SECTION

Camphor 4.0%
Menthol 4.0%

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 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 tightly.

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: Rub this soothing cream 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

Acacia Senegal Gum, Aloe Barbadensis Leaf Juice, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetyl Alcohol, Chondroitin Sulfate, D-Glucosamine Sulfate Potassium, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Eucalyptus Globulus Leaf/Twig Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Glycerin, Magnesium Chloride, Phenoxyethanol, Polysorbate 60, Thymol, Tocopherol, Urea, Vitis Vinifera (Grape) Seed Oil, Water, Xanthan Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Artwork 32ozArtwork 32oz

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
70039-303-04Professional Therapy MuscleCarePro115 g in 1 TUBECREAM1153
70039-303-16Professional Therapy MuscleCarePro453 g in 1 BOTTLE, PUMPCREAM4533
70039-303-32Professional Therapy MuscleCarePro906 g in 1 BOTTLE, PUMPCREAM9063

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70039-303PROFESSIONAL THERAPY MUSCLECARE PRO (MENTHOL AND CAMPHOR) CREAM [ACTIVE AND INNOVATIVE, LLC]3Current NDC, 3 package rows20240504_17961a84-6bee-c75f-e063-6394a90af576.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70039-30370039-303-32, 70039-303-04, 70039-303-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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 ProMENTHOL AND CAMPHORACTIVE AND INNOVATIVE, LLC17961a84-6bee-c75f-e063-6394a90af5762024-05-03WarningsExact identifier
ndc (package): 70039-303-04
ndc (package): 70039-303-32
ndc (package): 70039-303-16
ndc (product): 70039-303
ndc11 (package): 70039030316
ndc11 (package): 70039030332
ndc11 (package): 70039030304
spl id: 17961a30-5dd4-cae6-e063-6394a90a3faf
spl set id: 17961a84-6bee-c75f-e063-6394a90af576

Reported adverse events (FAERS/openFDA)#

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