Label: MYO-BREATHE- menthol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 41391-120-16, 41391-120-19 - Packager: Myo-Breathe,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 6, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
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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. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MYO-BREATHE
menthol sprayProduct 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)
