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

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- Bulk

Drug Facts

Active IngredientsPurpose
Lidocaine 4 % (240 mg)Topical analgesic
Menthol 1%     (60 mg)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

Dihydroxyaluminium aminoacetate, disodium EDTA, glycerin, methylparaben, polyvinyl alcohol, propyl
paraben, propylene glycol, purified water, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric
acid, titanium dioxide

Bulk

HOT AND COLD LIDOCAINE WITH MENTHOL PATCH  PAIN RELIEF
lidocaine and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71811-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE240 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL60 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71811-002-05500 in 1 CASE11/22/2019
11 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/22/2019
Labeler - INTERMED (676244169)

Revised: 11/2019
Document Id: 97f1d16c-0526-4282-e053-2995a90a5acd
Set id: 3f3a4912-27b7-4a49-8880-a9cc162c93b0
Version: 2
Effective Time: 20191122
 
INTERMED