LEADER LIDOCAINE- lidocaine hcl liquid 
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% Roll On

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

Flammable •Keep away from fire or flame

If pregnant or breast-feeding, ask a health professional before use

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

Questions or comments?

call 515-276-1586

Principal display panel

lidocaine front label

Leader

NDC 70000-0099-1

Maximum Strength

Lidocaine

Pain Relief

Liquid

Lidocaine HCl, 4% Topical Analgesic

No Mess

Applicator

Compare to

Aspercreme

Lidocaine liquid

active ingredient

100% Money Back Guarantee

2.5 Fl oz (73 mL)

LEADER LIDOCAINE 
lidocaine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
STEARETH-21 (UNII: 53J3F32P58)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0099-11 in 1 CARTON10/20/2021
173 mL 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 finalpart34810/20/2021
Labeler - CARDINAL HEALTH (063997360)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028manufacture(70000-0099)

Revised: 1/2022
Document Id: d3499047-8807-7fe9-e053-2a95a90a19bb
Set id: cece6765-0e2f-5ce9-e053-2995a90a3758
Version: 2
Effective Time: 20220105
 
CARDINAL HEALTH