Label: GERMA GEL DEL ARTICO- menthol 1% ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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

  • Active Ingredient

    Methyl Salicylate 10%

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, strains, sprains, arthritis and sports injuries.

  • INDICATIONS & USAGE

    When using this product do not • heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns • use on eyes or directly on mucous membranes • take by mouth or place in nostrils • apply to wounds or damaged skin • use on bandage skin • use, store, pour or spill near heat or open flame.

  • Purpose

    Topical Analgesic

  • Warnings

    For external use only ■ Use only as directed

    Do not use • on children • with a heating pad • with a tight bandage • on eyes, mucous membranes, wound or irritated skin • over extensive areas of the body.

  • Warnings

    KEEP OUT OF THE REACH OF CHILDREN

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • ASK DOCTOR

    Consult a doctor and discontinue use • If condition worsens or symptoms persist for more than 7 days • If you have sensitive skin • if prone to allergic reaction from any of the ingredients.

  • Other Information

    Store at controlled room temperature 15-30ºC (59-86ºF)

  • Directions

    Clean skin of lotions, creams, ointments, liniment or sprays • Apply liberally to affected area and massage until absorbed into skin • Do not apply more than 3 or 4 times daily. • Children under 12 years of age, ask a doctor.

  • Inactive Ingredients

    Camphor, D&C Color Red #17, Eucalyptus Oil, Lanolin Oil, Menthol, Mineral Oil, Paraffin Wax, Propylparaben, Tea Tree Oil, White Petrolatum.

  • Principal Display Panel

    gel del artico

  • INGREDIENTS AND APPEARANCE
    GERMA GEL DEL ARTICO 
    menthol 1% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73635-5802
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOTHIAZOLINONE (UNII: E57JT172V7)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73635-5802-9255.14 mL in 1 JAR; Type 0: Not a Combination Product03/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/29/2019
    Labeler - Germa Products, LLC (116626935)