MYO-BREATHE (MENTHOL) SPRAY [MYO-BREATHE,LLC]

  • Home
  • MYO-BREATHE (MENTHOL) SPRAY [MYO-BREATHE,LLC]

MYO-BREATHE (MENTHOL) SPRAY [MYO-BREATHE,LLC]
PDF | XML
NDC 41391-120-16, 41391-120-19
Set ID 53dfc79e-916d-49ad-aa5c-5af72a3eaec3
Category HUMAN OTC DRUG LABEL
Packager Myo-Breathe,LLC
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • Active IngredientMenthol 10.0%

  • Purpose(Topical Analgesic)

  • UsesTemporary relief from minor aches and pains of muscles and jointsassociated with: • simple backaches • arthritis • strains • bruises• sprains

  • WarningsFor external use onlyFlammable: Keep away from excessive heat or open flame

    Ask a doctor before use if you have:

    Sensitive skin

    When using this product:

    • Avoid contact with eyes or mucous • Use only as directed membranes • Do not bandage tightly or use a heating pad • Do not apply to wounds or damaged skin• Wash hands after use with cool water 

    Stop use and ask a doctor if:

    Condition worsens, or if symptoms persist for more than 7 days
    or clear up and occur again. • redness is present • excessive irritation of the skin develops.

    If pregnant or breast-feeding:

    Ask a health professional before use

    Keep out of reach of children:

    If swallowed, get medical help or contact a Poison Control
    Center right away.

    Adults and children 12 years of age and older:

    Spray directly onto affected area not more than 4  times daily; without the need to massage or bandage • repeat as necessary • Children 12 years or younger: Consult a physician before use.

    call 800-803-1535
  • PRINCIPAL DISPLAY PANEL

     mb_4oz_spray_copy.jpg

  • INGREDIENTS AND APPEARANCE
    MYO-BREATHE 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41391-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAMPHOR (natural) (UNII: N20HL7Q941)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41391-120-16118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:41391-120-19473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/15/2015
    Labeler - Myo-Breathe,LLC (003635412)
View All Sections

Related Drugs

Search DailyMed Drugs