HOT AND COLD LIDOCAINE WITH MENTHOL PATCH  PAIN RELIEF- lidocaine and menthol patch 
Velocity Pharma 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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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

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 Menthol lido patch

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
Inactive Ingredients
Ingredient NameStrength
ALGELDRATE (UNII: 03J11K103C)  
BENTONITE (UNII: A3N5ZCN45C)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLEIC ACID (UNII: 2UMI9U37CP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TARTARIC ACID (UNII: W4888I119H)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
TROLAMINE (UNII: 9O3K93S3TK)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-099-115 in 1 CARTON03/03/2017
11 in 1 POUCH; Type 0: Not a Combination Product
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/FEIBusiness Operations
DR SABHARWALS WOUND CARE862184668manufacture(76168-099)

Revised: 3/2017
Document Id: 49da2f87-9520-74e8-e054-00144ff8d46c
Set id: d96693a5-910d-4f85-8bd0-7dd01e5f83d2
Version: 2
Effective Time: 20170303
 
Velocity Pharma LLC