MUSCLE RUB CREAM- menthol 10%, methyl salicylate 15% cream 
Trifecta Pharmaceuticals USA, LLC.

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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Muscle Rub Cream

Drug Facts

Active Ingredient

Menthol 10%

Active Ingredient

Methyl Salicylate 15%

Topical Analgesic

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

Warnings

For external use only

Do not use:

Ask a doctor before use if you are pregnant or breast feeding.

When using this product

Stop Use and ask a doctor

A temporary burning sensation may occur upon application, but generally disappears in a few days

Keep out of the reach of Children

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

Directions

Children under 12 years of age. consult a doctor

Other Information

Questions ? Call 1-888-296-9067

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Distributed By

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

Packaging

Globe Muscle Cream

MUSCLE RUB CREAM 
menthol 10%, methyl salicylate 15% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-024-051 in 1 BOX12/29/2016
115 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 finalpart34812/29/2016
Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 1/2023
Document Id: f276c9eb-88f9-64d7-e053-2a95a90a8952
Set id: 44d3638d-f29b-0e01-e054-00144ff88e88
Version: 4
Effective Time: 20230117
 
Trifecta Pharmaceuticals USA, LLC.