LEADER BURN RELIEF- lidocaine spray 
Cardinal Health

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Leader Burn Relief Spray, Lidocaine 0.5%

Lidocaine 0.5%

External Analgesic.

For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritations.

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 avoid contact with eyes. Rinse with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

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

Water, Alcohol Denat., Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Disodium Cocoamphodipipropionate, Carbomer, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Propylparaben, methylparaben, Simethicone.

Label

LEADER BURN RELIEF 
lidocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0624
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0624-1128 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/17/2023
Labeler - Cardinal Health (063997360)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(70000-0624)

Revised: 2/2024
Document Id: 10ba9afc-73fc-c8a3-e063-6294a90a8adc
Set id: f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2
Version: 2
Effective Time: 20240206
 
Cardinal Health