Label: GERMA UBRE MASTITIS- methyl salicylate 2% ointment

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

Drug Label Information

Updated October 15, 2024

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

  • Active Ingredient

    Methyl Salicylate 2%

  • Uses

    Temporary relief of minor pain n joint & muscular aches n strains & sprain n backache.

  • INDICATIONS & USAGE

    Do not use, if prone to allergic reaction from any of the ingredients.

    Do not use n on children • on irritated skin • in or near eyes or mucous membranes • on wounds or damaged skin.

  • Purpose

    Topical Analgesic

  • Warnings

    For external use only

    Do not use on large areas of the body. • if you are taking any other medication or drinking alcohol • if safety seal is torn, broken or missing.

  • Warnings

    KEEP OUT OF THE REACH OF CHILDREN

    In case of accidental ingestion, get help or contact a Poison Control Center immediately.
    Do not use • on children • on irritated skin • in or near eyes or mucous membranes • on wounds or damaged skin n if prone to allergic reaction from any of the ingredient n on large areas of the body. • if you are taking any other medication or drinking alcohol • if safety seal is torn, broken or missing.

  • PREGNANCY OR BREAST FEEDING

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

  • ASK DOCTOR

    Stop use and ask a doctor n if condition worsens or cleans up and occurs again n if symptoms persist for more than 7 days or irritation or severe burning occurs.

  • Other Information

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

  • Directions

    Adults and children 12 years and older; apply to the affected area • no more than 3 to 4 times daily n children under 12 years of age; ask a Doctor.

  • Inactive Ingredients

    Camphor crystals, D&C Brown #1, Lanolin, Ichthammol, and white petrolatum.

  • PRINCIPAL DISPLAY PANEL

    Ubre mastitis

  • INGREDIENTS AND APPEARANCE
    GERMA UBRE MASTITIS 
    methyl salicylate 2% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73635-5807
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    D&C BROWN NO. 1 (UNII: 8796B4I6HE)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    ICHTHAMMOL (UNII: NQ14646378)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73635-5807-256.69 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 DrugM01403/29/2019
    Labeler - Germa Products, LLC (116626935)