PROFESSIONAL THERAPY MUSCLECARE PAIN RELIEVING GEL EXTRA STRENGTH- camphor, menthol 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.

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

Active Ingredients (% by weight) Purpose

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

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

Uses:

For 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 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:

Alcohol Denat., Acrylates Copolymer, Water, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint Oil), Propylene Glycol, Glycerin, MSM (Methylsulfonylmethane), Boswellia Serrata Extract, Ilex Paraguensis (Yerba Mate Ilex) Extract, Glucosamine Sulfate, Chondroitin Sulfate, Magnesium Chloride, Triethanolamine.

FOR MUSCLE & JOINT PAIN RELIEF

Extra Strength Pain Relieving Gel

by Dr. Chris Oswald

Net Wt

3oz. (85g)

Complete Label - MC rollon

PROFESSIONAL THERAPY MUSCLECARE PAIN RELIEVING GEL  EXTRA STRENGTH
camphor, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70039-283
Route of AdministrationCUTANEOUS, TOPICAL
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) MENTHOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
WATER (UNII: 059QF0KO0R)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
ALCOHOL (UNII: 3K9958V90M)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70039-283-071 g in 1 BOTTLE, WITH APPLICATOR; 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(70039-283)

Revised: 8/2016
Document Id: 39bd979f-91a1-0554-e054-00144ff8d46c
Set id: 1d2403d9-99c3-24f5-e054-00144ff8d46c
Version: 2
Effective Time: 20160810
 
Active and Innovative Inc.