Label: CAMPHOR gel

  • NDC Code(s): 49283-331-04, 49283-331-05, 49283-331-28
  • Packager: Chemco Corporation
  • Category: HUMAN OTC DRUG LABEL

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 June 23, 2020

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  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • INACTIVE INGREDIENT

  • INDICATIONS & USAGE

  • KEEP OUT OF REACH OF CHILDREN

  • PURPOSE

  • ACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    gel 4ozGel 5galicegel 128oz

  • INGREDIENTS AND APPEARANCE
    CAMPHOR 
    camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL94.8 mL  in 99 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    WATER (UNII: 059QF0KO0R)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    OLETH-20 (UNII: YTH167I2AG)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DIPROPYLENE GLYCOL MONOCAPRATE MONOCAPRYLATE (UNII: 5980W979EL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49283-331-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
    2NDC:49283-331-0518927 mL in 1 PAIL; Type 0: Not a Combination Product06/23/2020
    3NDC:49283-331-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/11/2020
    Labeler - Chemco Corporation (032495954)
    Registrant - Chemco Corporation (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemco Corporation032495954manufacture(49283-331)