Label: FLEXILON- methyl salicylate, menthol, camphor cream

  • NDC Code(s): 72826-101-14
  • Packager: Semprae Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 31, 2022

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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:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    For external use only

  • Do not use

    • on wounds or damaged , broken or irritated skin 
    • with a heating pad
  • When using this product

    • avoid contact with eyes or mucous membranes 
    • do not bandage tightly
  • Stop use and ask a doctor if

    • condition worsens 
    • you have redness over the affected area 
    • symptoms persist for more than 7 days or symptoms clear up and occur within a few days 
    • excessive skin irritation occurs
  • Keep out of reach of children

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

  • DIRECTIONS

    • use only as directed 
    • Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 12 years of age: consult a doctor.
  • 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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    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)
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