Label: GERMA LINIMENTO UBRE PLUS (ROLL-ON)- methyl salicylate 10% ointment

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

Drug Label Information

Updated October 19, 2023

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  • 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

  • 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

    Capsaicin, Carbomer, Eucalyptus Oil, Isopropyl Alcohol, Menthol Crystals, Polysorbate 20, Propylene Glycol, Triethanolamine and Water.

  • PRINCIPAL DISPLAY PANEL

    Ubre Plus Roll-On

  • INGREDIENTS AND APPEARANCE
    GERMA LINIMENTO UBRE PLUS (ROLL-ON) 
    methyl salicylate 10% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73635-5806
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73635-5806-388.5 mL in 1 APPLICATOR; 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)