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Hot and Cold Lidocaine with Menthol Patch Pain Relief

Medically reviewed on March 3, 2017

Dosage form: patch
Ingredients: LIDOCAINE 40mg, MENTHOL 10mg
Labeler: Velocity Pharma LLC
NDC Code: 76168-099

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.

Hot and Cold Lidocaine with Menthol Patch

Drug Facts

Active IngredientsPurpose
Lidocaine 4 %Topical analgesic
Menthol 1%Topical analgesic

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warnings

For external use only.

Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.

When using this product
  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not apply to open wounds or sensitive skin
  • do not bandage tightly or use a heating pad

Stop use and ask a doctor if
  • excessive redness or irritation is present
  • condition worsens
  • pain persists for more than 7 days
  • symptoms clear up and occur again within a few days

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: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
  • children: consult your physician
  • remove protective film, gently apply to affected area.

Inactive Ingredients

aluminium hydroxide gel, bentonite, borax, carbomer, carboxymethylcellulose sodium,
colloidal silicon dioxide, dihydroxyaluminumaminoacetate, disodiumedetate, gelatin, glycerin, oleic acid, polysorbate 80, polyvinyl Alcohol, potassium Sorbate, povidone, propylene glycol, sodiummetabisulphite, tartaric acid, trolamine, urea, water

PRINCIPAL DISPLAY PANEL - 3 Topical Patch Carton

CONTAINS LIDOCAINE with Menthol

PAIN RELIEF PATCH

5TOPICAL PATCHES PER BOX

HOT AND COLD LIDOCAINE WITH MENTHOL PATCH   PAIN RELIEF
lidocaine and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-099
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE40 mg
MENTHOL (MENTHOL) MENTHOL10 mg
Inactive Ingredients
Ingredient NameStrength
ALGELDRATE 
BENTONITE 
SODIUM BORATE 
CARBOMER 940 
CARBOXYMETHYLCELLULOSE SODIUM 
SILICON DIOXIDE 
DIHYDROXYALUMINUM AMINOACETATE 
GELATIN 
GLYCERIN 
OLEIC ACID 
POLYSORBATE 80 
POLYVINYL ALCOHOL, UNSPECIFIED 
POTASSIUM SORBATE 
POVIDONE 
PROPYLENE GLYCOL 
TARTARIC ACID 
UREA 
WATER 
EDETATE DISODIUM ANHYDROUS 
TROLAMINE 
SODIUM METABISULFITE 
Packaging
#Item CodePackage Description
1NDC:76168-099-115 POUCH in 1 CARTON
11 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/03/2017
Labeler - Velocity Pharma LLC (962198409)
Registrant - Velocity Pharma LLC (962198409)
Establishment
NameAddressID/FEIOperations
DR SABHARWALS WOUND CARE862184668manufacture(76168-099)

 
Velocity Pharma LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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