Label: MYO-BREATHE- menthol gel

  • NDC Code(s): 41391-119-11, 41391-119-12, 41391-119-13, 41391-119-19
  • Packager: Myo-Breathe,LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/15

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

  • PURPOSE

    Purpose: Topical Analgesic

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  • INDICATIONS & USAGE

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

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  • 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

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  • PRINCIPAL DISPLAY PANEL

                mb_4oz_gel_copy.jpg

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  • ACTIVE INGREDIENT

    Active Ingredient: Menthol 4%

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  • INGREDIENTS AND APPEARANCE
    MYO-BREATHE 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41391-119
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol 40 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white (off white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41391-119-11 5 mL in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:41391-119-12 118 mL in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:41391-119-13 89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    4 NDC:41391-119-19 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/10/2009
    Labeler - Myo-Breathe,LLC (003635412)
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