LEADER  BURN RELIEF- lidocaine hydrochloride gel 
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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Leader Burn Relief Gel

Active ingredient

Lidocaine 1.0% (as Lidocaine HCl)

Purpose

External analgesic

Uses

temporarily relieves pain and itching due to:

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas

When using this product

Avoid contact with eyes. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

may stain some fabrics

Inactive ingredients

aloe barbadensis leaf juice, triethanolamine, isoceteth-20, carbomer, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, water, benzophenone-4, blue 1.

Label

CL13900

LEADER   BURN RELIEF
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0537
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOCETETH-20 (UNII: O020065R7Z)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SULISOBENZONE (UNII: 1W6L629B4K)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0537-1226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/04/2019
Labeler - Cardinal Health (063997360)

Revised: 11/2022
Document Id: ecb1e0a4-1731-d4cf-e053-2995a90aaf79
Set id: 98e61979-6ce4-5033-e053-2995a90a2905
Version: 2
Effective Time: 20221104
 
Cardinal Health