Label: KERATEK- menthol, methyl salicylate gel

  • 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 October 21, 2013

If you are a consumer or patient please visit this version.

  • DRUG FACTS

    Active Ingredients                            Purpose

    Menthol 16%                          Topical analgesic

    Methyl Salicylate 28%             Topical analgesic

  • USES

    Temporarily retieves the minor aches and pains of muscles and joints associated with single

    backache, arthritis, strains, bruises and sprains.

  • 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 ask a doctor

  • Warnings

    For external use only

    Do not use on wounds of damaged skin or with a heating pad or on a child under 12 years of age with arthritis-like conditions.

    Ask doctor before use if you have redness over the affected area.

    When using this product

    Avoid contact with eyes or mucous membranes do not bandage tightly

    Stop use and ask a doctor if

    condition worsens or symptoms persist for more than 7 days

    symtoms clear up and occur again within a few days

    excessive skin irritation occurs

  • Inactive Ingredients

    Arnica, carbomer, cetyl alcohol, dmdm hydantoin, edetate disodium, lanolin, methyl paraben, paraffin wax, peg 40 hydrogenated castor oil,

    peg 100 stearate, petrolatum, polygel w400, polysorbate 80, propyl paraben, purified water, stearic acid.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion. if swallowed, get medical help or

    contact a Poison Control Center Immediately

  • STORAGE AND HANDLING

    Store at 20' to 25'C (68' to 77'F)

  • DOSAGE & ADMINISTRATION

    Apply to affected area not more than 3 to 4 times daily.

  • PRINCIPAL DISPLAY PANEL

    Label of Bottle

  • INGREDIENTS AND APPEARANCE
    KERATEK 
    menthol, methyl salicylate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-540
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE28 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-540-04113 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/21/2013
    Labeler - GERITREX CORP (112796248)
    Registrant - GERITREX CORP (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX CORP112796248manufacture(54162-540)