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

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MYO-BREATHE (MENTHOL) GEL [MYO-BREATHE,LLC]
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NDC 41391-119-11, 41391-119-12, 41391-119-13, 41391-119-19
Set ID 40fa3155-b568-4f2a-ad9e-ea18a039d2f8
Category HUMAN OTC DRUG LABEL
Packager Myo-Breathe,LLC
Generic Name
Product Class
Product Number
Application Number PART346
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  • 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)
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