PROFESSIONAL THERAPY MUSCLECARE- camphor, menthol cream 
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 ointment, 4oz

FOR MUSCLE & JOINT PAIN RELIEF

Active Ingredietns (% by weight) Purpose

Camphor 4%.........................Analgesic (pain relief)

Menthol 4%...........................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.

Keep out of reach of children.

Directions: 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: Store under normal storage conditions. Store away from children.

Inactive Ingredients: Water/Aqua, Cetyl Alcohol, Glycol Stearate, MSM (methylsulfonylmethane), Glycerin,

Stearyl Alcohol, Glucosamine Sulfate, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Tocopherol (Vitamin E) Acetate, Oil of Wintergreen (Methyl Salicylate), Grape Seed Oil, Sea Cucumber (Stichopus Horrens) Extract, Urea, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Polysorbate-20, Eucalyptus Globulus Leaf Oil, Thymol, Aloe Barbadensis Leaf Juice, Chondroitin Sulfate, Magnesium Chloride

Professionl Therapy MuscleCare Maximum Strength Pain Relieving Ointment by Dr. Chris Oswald

Full product label. Full product label

PROFESSIONAL THERAPY MUSCLECARE 
camphor, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70039-298
Route of AdministrationTOPICAL, CUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCOL STEARATE (UNII: 0324G66D0E)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SORBIC ACID (UNII: X045WJ989B)  
THYMOL (UNII: 3J50XA376E)  
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
STICHOPUS SEA CUCUMBER (UNII: RO6YEJ571T)  
(HYDROXYMETHYL)UREA (UNII: 15BY095DMS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70039-298-08115 g in 1 TUBE; Type 0: Not a Combination Product06/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2015
Labeler - Active and Innovative Inc. (206978079)
Establishment
NameAddressID/FEIBusiness Operations
PureTek Corp.785961046manufacture(70039-298)

Revised: 8/2016
Document Id: 39cf0152-0f2a-1077-e054-00144ff8d46c
Set id: 1ec95bbb-cd7d-2588-e054-00144ff8d46c
Version: 2
Effective Time: 20160811
 
Active and Innovative Inc.