LIDALL- lidocaine patch 
MedVantage Pharmaceutical, 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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LidAll Pain Relieving Patch

Warnings

For external use only

Do not use

■ other than directed

 ■ on wounds

 ■ on damaged skin

■if you are allergic to menthol

 ■ in large quantities, particularly over raw services or blistered areas

When using this product

■ avoid contact with the eyes or mucous membranes

■ do not bandage tightly

Stop use and ask a doctor

■ excessive irritation of the skin develops

 ■ condition worsens

■symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Active ingredients

Lidocaine 4%

Menthol 1%

Inactive ingredients

Aloe (Aloe Barbadensis) Leaf Juice, Diazolidinyl Urea, EDTA Disodium Salt, Glycerin, Iodopropynyl Butylcarbamate,

Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, Water

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Directions

■Clean and dry affected area. Cut open pouch and remove patch.

■Remove protective film and apply directly to affected area.

■Wash hands with soap after applying patch.

■Reseal pouch containing unused patches.

■Adults and children 12 years of age and older: Apply to affected area; change patch 1 to 2 times daily. Do not apply

to affected are more than 3 times daily.

■Children under 12 years of age: Consult a physician before use.

Purpose

Pain relief

Use

■For the temporary relief of pain and itching associated with minor skin irritations.

Other information

Store below 77 º F (25º C). Avoid direct sunlight.

image description

LIDALL 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64533-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETIC ACID (UNII: 9G34HU7RV0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64533-000-01100 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2013
Labeler - MedVantage Pharmaceutical, LLC (079094932)
Registrant - MedVantage Pharmaceutical, LLC (079094932)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture(64533-000)

Revised: 4/2014
Document Id: 7bf5069b-3d80-4018-8297-ee4f73f67b39
Set id: daba204e-2e7a-44ab-a692-088303c90af5
Version: 4
Effective Time: 20140429
 
MedVantage Pharmaceutical, LLC