MUSCLECARE PROFESSIONAL THERAPY PAIN RELIEVING- camphor and menthol gel 
Active and Innovative

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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Drug Facts

Active Ingredients (% by weight)

Camphor 4.0%

Menthol 10.0%

Purpose

Analgesic (Pain Relief)

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. Using the roll-on applicator, message a liberal amount of gel directly on the affected area not more than 3 to 4 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 (Methylsulfonymethane), Boswellia Serrata Extract,  Glucosamine Sulfate, Chondroitin Sulfate, Magnesium Chloride, Triethanolamine

Questions?

416-967-3746

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MuscleCare_Extra_Strength_Rollon_3oz

MUSCLECARE  PROFESSIONAL THERAPY PAIN RELIEVING
camphor and menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.5 g  in 85 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.4 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
WATER (UNII: 059QF0KO0R)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
SULFATE ION (UNII: 7IS9N8KPMG)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-026-0785 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/21/2011
Labeler - Active and Innovative (961956229)
Registrant - Creations Garden Natural Products (961956229)
Establishment
NameAddressID/FEIBusiness Operations
Creations Garden Natural Products961956229manufacture

Revised: 6/2011
Document Id: ad3b4c32-eff7-466a-91de-4b6bf1a0e5a1
Set id: de0e4995-c62c-4468-80f0-ef64e7369b94
Version: 1
Effective Time: 20110621
 
Active and Innovative