MYO-BREATHE- menthol spray 
Myo-Breathe,LLC

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.

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Drug Facts

Active Ingredient
Menthol 10.0%


Purpose(Topical Analgesic)

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

Warnings
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:

• 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

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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)

Revised: 5/2015
Document Id: 52bfd151-d250-4696-9690-38b5be8b2ea3
Set id: 53dfc79e-916d-49ad-aa5c-5af72a3eaec3
Version: 1
Effective Time: 20150506
 
Myo-Breathe,LLC