Label: MYO-BREATHE- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 April 21, 2015

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • PURPOSE

    Purpose: Topical Analgesic

  • INDICATIONS & USAGE

    Uses: Temporary relief from minor aches and pains of muscles and joints
    associated with: • simple backaches • arthritis • strains • bruises
    • sprains

  • WARNINGS

    Warning: For external use only
    Flammable: Keep away from excessive heat or open flame

    Ask a doctor before use if you have:
    Sensitive skin

    When using this product: • Use only as directed • Avoid contact with eyes or mucous
    membranes • Do not apply to wounds or damaged skin • Do not bandage tightly or use with
    a heating pad

    Stop use and ask a doctor if:Condition worsens, or if symptoms persist for more than 7 days
    or clear up and occur again.

    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.

    Directions: Adults and children 12 years of age and older:
    Apply to affected area not more than 3 to 4 times daily.
    Massage into painful area until thoroughly absorbed into skin

    Children under 12 years of age: Consult a physician before use.

    Questions or Comments? 1-800-803-1535

  • PRINCIPAL DISPLAY PANEL

                mb_4oz_gel_copy.jpg

  • ACTIVE INGREDIENT

    Active Ingredient: Menthol 4%

  • INGREDIENTS AND APPEARANCE
    MYO-BREATHE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41391-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR (natural) (UNII: N20HL7Q941)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Colorwhite (off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41391-119-115 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:41391-119-12118 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41391-119-1389 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    4NDC:41391-119-19473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/10/2009
    Labeler - Myo-Breathe,LLC (003635412)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!