Your browser does not support JavaScript! MYO-BREATHE (MENTHOL) GEL [MYO-BREATHE]
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MYO-BREATHE (menthol) gel
[Myo-Breathe]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active Ingredient
Menthol 3.5%

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:

• 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.

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

call 800-803-1535

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MYO-BREATHE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41391-119
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (MENTHOL) Menthol4000 mg  in  4 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CAMPHOR (natural) 
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES 
CARBOMER 934 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
LECITHIN, SOYBEAN 
DIMETHYL SULFONE 
PHENOXYETHANOL 
SORBIC ACID 
ALPHA-TOCOPHEROL ACETATE 
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
2NDC:41391-119-12118 mL in 1 TUBE
3NDC:41391-119-1389 mL in 1 BOTTLE, WITH APPLICATOR
4NDC:41391-119-14946 mL in 1 BOTTLE, PUMP
5NDC:41391-119-153785 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/10/2009
Labeler - Myo-Breathe (003635412)

Revised: 4/2013
 
Myo-Breathe

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