BURN RELIEF LEADER- lidocaine spray 
Cardinal Health

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 0.50%

Uses

Temporarily relieves pain and itching due to:  sunburn, minor burns, minor cuts, scrapes, insect bites, minor skin irritations.

Warnings

For external use only.  Flammable:  do not use while smoking or near heat or flame.  Do not use in large quantities, particularly over raw surfaces or blistered areas.  When using this product:  keep out of eyes, use only as directed, do not puncture or incinerate.  Contents under pressure.  Do no store at temperatures above 120 deg F. Stop use and ask doctor if:  condition gets worse, symptoms last more than 7 days, or symptoms clear up and occur again in a few days. 

Directions

Shake well.  Adults and children 2 years of age and older:  apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age:  ask a doctor.  To apply to face, spray into palm of hand and gently apply.

Inactive ingredients

Aloe Barbadensis Leaf Juice, SD Alcohol 40, Propylene Glycol, Glycerin, Simethicone, Tocopheryl Acetate, Triethanolamine, Carbomer, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium Cocoamphodipropionate, Disodium EDTA.

Purpose

External analgesic.

Keep out of reach of children.

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

Burn Relief Spray with Lidocaine.

Can image


BURN RELIEF  LEADER
lidocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-613
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Aloe (UNII: V5VD430YW9)  
Alcohol (UNII: 3K9958V90M)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Glycerin (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Edetate Disodium (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-613-11127 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34812/01/2011
Labeler - Cardinal Health (097537435)

Revised: 1/2011
Document Id: ee2d253f-7730-4e59-bc4a-af6f17a2ddad
Set id: fa64a861-2c70-4ba5-b302-a48a0de8c1da
Version: 1
Effective Time: 20110111
 
Cardinal Health