LIDOCAINE 4% PLUS MENTHOL 1%- lidocaine, menthol patch 
Icure Pharmaceutical Inc, Wanju Factory

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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Drug Facts

lidocaine, menthol

Methylparaben, Propylparaben, Sodium Polyacrylate, Polyacrylic Acid 20% Solution, Gelatin, Carboxymethyl Cellulose, Titanium Oxide, Kaolin, Dihydroxyaluminium Aminoacetate, Concentrated Glycerin, D-Sorbitol Solution, Urea, Polysorbate 80, Sorbitan Oleate, Disodium Edetate Hydrate, Tartaric Acid, Propylene Glycol, Purified Water

Temporary relief of minor pain

keep out of reach of the children

Use only as directed. Read and follow all directions and warnings on this label.
Do not allow contact with the eyes and mucous membranes
Do not bandage tightly or apply local heat (such as heating pads) to the area of use
Do not use at the same time as other topical analgesics
Dispose of used patch in manner that always keeps product away from children and pets
Used patch still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests patch

- Warnings
For external use only.
Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients.

- Do not Use
More than 1 patch on your body at a time or on cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctor

for external use only

label

LIDOCAINE 4% PLUS MENTHOL 1% 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73279-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73279-0001-25 in 1 POUCH08/31/2019
1NDC:73279-0001-16 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2019
Labeler - Icure Pharmaceutical Inc, Wanju Factory (695687612)
Registrant - Icure Pharmaceutical Inc, Wanju Factory (695687612)
Establishment
NameAddressID/FEIBusiness Operations
Icure Pharmaceutical Inc, Wanju Factory695687612manufacture(73279-0001) , label(73279-0001)

Revised: 9/2019
Document Id: 91b0d55e-7520-926e-e053-2a95a90a55c0
Set id: 91b0d5d6-bfa1-2b78-e053-2995a90aacf7
Version: 1
Effective Time: 20190903
 
Icure Pharmaceutical Inc, Wanju Factory