Label: MENTHOL, LIDOCAINE, CAMPHOR gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 27, 2021

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  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • INACTIVE INGREDIENT

  • INDICATIONS & USAGE

  • KEEP OUT OF REACH OF CHILDREN

  • ACTIVE INGREDIENT

  • PURPOSE

  • PRINCIPAL DISPLAY PANEL

    3.18 oz

  • INGREDIENTS AND APPEARANCE
    MENTHOL, LIDOCAINE, CAMPHOR 
    menthol, lidocaine, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-541
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    BASIC BLUE 1 (UNII: 92N74OA24D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49283-541-0390 g in 1 BOTTLE; Type 0: Not a Combination Product07/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/27/2021
    Labeler - CHEMCO CORPORATION (032495954)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(49283-541)