MYO-BREATHE- menthol spray

Myo-Breathe by

Drug Labeling and Warnings

Myo-Breathe by is a Otc medication manufactured, distributed, or labeled by Myo-Breathe,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

 

INGREDIENTS AND APPEARANCE

MYO-BREATHE 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41391-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41391-120-16	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 41391-120-19	473 mL in 1 BOTTLE, SPRAY; 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	02/15/2015

Labeler - Myo-Breathe,LLC (003635412)