MYO-BREATHE- menthol gel 
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

Purpose: Topical Analgesic

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

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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Active Ingredient: Menthol 4%

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)

Revised: 4/2015
Document Id: efeb468c-631c-4c9f-ba4c-7e1576c277c2
Set id: 40fa3155-b568-4f2a-ad9e-ea18a039d2f8
Version: 4
Effective Time: 20150421
 
Myo-Breathe,LLC