PROFESSIONAL THERAPY MUSCLECARE EXTRA STRENGTH- menthol, camphor gel 
Active and Innovative Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Professional Therapy MuscleCare pain relieving gel, 3 oz. roll-on

For Muscle and Joint Pain Relief

ACTIVE INGREDIENTS (% BY WEIGHT) PURPOSE

Camphor 4.0%.................. Analgesic (pain relief)

Menthol 10.0%...................Analgesic (pain relief)

USES:

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

WARNINGS:

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:

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: Adults and children 12 years of age or older: Using the roll-on applicator massage a liberal amount of gel directly onto 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: Store under normal storage conditions. Store away from children.

Inactive Ingredients: Peppermint leaf oil (Mentha piperita), Eucalyptus globus leaf oil, Dimethyl sulfone (MSM), Boswellia Carterii Extract, Ilex Paraguariensis (Mate) leaf extract, Glucosamine sulfate, Chondroitin sulfte, Magnesium chloride, Tocopherol (natural Vitamin E), Thymol crystals (5-methyl-2-(1-methylethyl)phenol), Water, Ethanol, Glycerin, UREA, Hydroxypropyl methylcellulose.

Professional Therapy MuscleCare Extra Strength Pain Relieving Gel by Dr. Chris Oswald

Full Label

PROFESSIONAL THERAPY MUSCLECARE  EXTRA STRENGTH
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70039-200
Route of AdministrationCUTANEOUS, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL (UNII: 2R04ONI662)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
TOCOPHEROL (UNII: R0ZB2556P8)  
THYMOL (UNII: 3J50XA376E)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
UREA (UNII: 8W8T17847W)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70039-200-0285 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2017
Labeler - Active and Innovative Inc. (206978079)
Establishment
NameAddressID/FEIBusiness Operations
Delta Pharma Inc.200161730manufacture(70039-200)
Establishment
NameAddressID/FEIBusiness Operations
PureTek Corporation785961046manufacture(70039-200)

Revised: 8/2021
Document Id: c8af1885-9106-25c3-e053-2a95a90ae185
Set id: 42f2ac23-0c14-249c-e054-00144ff8d46c
Version: 2
Effective Time: 20210803
 
Active and Innovative Inc.