FLEXILON- methyl salicylate, menthol, camphor cream 
Semprae Laboratories 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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ACTIVE INGREDIENT

Camphor 4%

Menthol 7.5%

Methyl Salicylate 10%

PURPOSE

Topical analgesic

USES

For the temporary relief of minor aches and pains of muscles and joints associated with:

WARNINGS

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children

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

DIRECTIONS

OTHER INFORMATION

store at 20-25C (68-77F)

Do not purchase if outer seal is broken

INACTIVE INGREDIENTS

carbomer, cetearyl alcohol, D.I. water, FD&C Blue no. 1, FD&C Yellow no.5, glucosamine sulfate, glyceryl monostearate, methyl sulfonyl methane,
methylparaben, mineral oil 90, PEG-100, propylparaben, polysorbate 60, stearyl alcohol, triethanolamine

image description

FLEXILON 
methyl salicylate, menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72826-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72826-101-141 in 1 CARTON11/10/2020
156.7 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/10/2020
Labeler - Semprae Laboratories Inc (093739668)
Registrant - Semprae Laboratories Inc (093739668)

Revised: 12/2022
Document Id: 806ad904-35cf-46f6-b9bb-1aa282c80866
Set id: dba920f3-27c8-4f69-a524-f99e57a276a0
Version: 2
Effective Time: 20221231
 
Semprae Laboratories Inc