MUSCLE AND JOINT- menthol gel 
Kareway Product, 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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Sound Body Muscle and Joint Rub

Active ingredient

Menthol 2.5%

purpose

Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

Warnings

For external use only

Do not use

  • on wound s or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have

redness over the affected area.

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

camphor, carbomer 940, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

Questions or Comments?

1-800-833-0085

Package label

Muscle and joint pain relief rub image of carton label

MUSCLE AND JOINT 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0634
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0634-41 in 1 BOX12/12/2013
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/12/2013
Labeler - Kareway Product, Inc. (121840057)

Revised: 11/2022
Document Id: eda70b68-5c20-387b-e053-2a95a90ab5b2
Set id: 96f389d1-22e9-4744-bfbd-b55dd402ecae
Version: 6
Effective Time: 20221117
 
Kareway Product, Inc.