LEADER- lidocaine hcl cream 
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 Lidocaine HCL 4% Cream

Active ingredient

Lidocaine HCl 4%

Purpose

Topical 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 do not get into eyes

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days

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

Directions

Other information

store between 20 °C and 25 °C (68 °F and 77 °F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,
C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

Principal display panel

Front Label

Leader

NDC 70000-0098-1

Maximum Strength

Lidocaine

Pain Relief

Cream

Lidocaine HCl 4% Topical Analgesic

Non Greasy

Compare to aspercreme lidocaine cream

active ingredient

100% Money Back Guarantee

Net wt 2.7 oz (76.5g)

Carton Label

LEADER 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
STEARETH-21 (UNII: 53J3F32P58)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0098-11 in 1 CARTON10/18/2021
176.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/18/2021
Labeler - Cardinal Health (063997360)
Registrant - Weeks & Leo Company Inc (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Company Inc005290028manufacture(70000-0098)

Revised: 10/2021
Document Id: cea6bd2d-a266-1209-e053-2995a90ab0a5
Set id: cea6bd2d-a265-1209-e053-2995a90ab0a5
Version: 1
Effective Time: 20211018
 
Cardinal Health