LEADER  AFTER SUN COOLING- lidocaine hydrochloride gel 
CARDINAL HEALTH, INC.

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 After Sun Cooling Gel

Active Ingredient

Lidocaine hydrochloride 0.5%

Purpose

External Analgesic

Uses

temporarily relieves pain and itching due to:

Warnings

​Do not use

​in large quantities, particularly over raw surfaces or blistered areas.

When using this product

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, water, isopropyl alcohol, propylene glycol, glycerin, triethanolamine, carbomer, polysorbate 80, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

Label

CL13898E-F

LEADER   AFTER SUN COOLING
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0534
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
MENTHOL (UNII: L7T10EIP3A)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0534-1226 g in 1 BOTTLE; Type 0: Not a Combination Product11/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/04/2019
Labeler - CARDINAL HEALTH, INC. (063997360)

Revised: 11/2022
Document Id: ecb10671-a18a-69dc-e053-2995a90ab6d9
Set id: 968b0056-3ab4-0a81-e053-2995a90ab69e
Version: 2
Effective Time: 20221104
 
CARDINAL HEALTH, INC.