MENTHOCIN PATCH WITH LIDOCAINE- methyl salicylate, menthol, capsaicin and lidocaine patch 
Bonita Pharmaceuticals 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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Menthocin Patch with Lidocaine

Active Ingredients

Menthol - 5.00%

Capsaicin - 0.035%

Methyl Salicylate - 20%

Lidocaine - 0.5%

Purpose

Topical Analgesic

Topical Anesthetic

Uses

Temporarily relieves minor aches and muscle pain associated with:

• Arthritis

• Simple backache

• Bursitis

• Tendonitis

• Bruises

• Cramps

• Muscle soreness and muscle stiffness

Warnings

For external use only.

When using this product,

• use only as directed

• do not cover with bandage

• avoid contact with eyes and mucous membranes

• do not apply to wounds or damaged skin

Stop use and ask a doctor if

• condition worsens
• symptoms persist more than 7 days or clear up and occur again within a few days
• redness is present
• skin irritation develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and children 12 years of age and older:

apply to affected area not more than 3 times daily

Children under 12 year of age:

do not use, consult a doctor

How to apply:

• Clean and dry affected area

• Partially remove protective film of patch and apply directly to area of pain.

• Carefully remove remaining film. Ensure secure adhesion.

• Reseal Pouch after opening

• Wash hands with soap after applying patch

Other Information

Store below 90°F/32°C

Avoid direct sunlight.

Inactive Ingredients

acrlic acid, aluminium hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

Questions?

If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.

Menthocin Patch with Lidocaine Label

box image front

MENTHOCIN PATCH  WITH LIDOCAINE
menthol, capsaicin, lidocaine, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53598-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.035 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ETHYLHEXYL ACETATE (UNII: 2C7K8OA8SB)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53598-010-055 in 1 BOX; Type 0: Not a Combination Product01/25/201508/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/25/201508/15/2015
Labeler - Bonita Pharmaceuticals LLC (004219442)

Revised: 8/2015
 
Bonita Pharmaceuticals LLC