TOPICAL PAIN RELIEF- lidocaine hcl liquid 
LEON MEDICAL CENTERS, 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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Lidocaine HCl, USP 4%

Topical Anesthetic

Use

Temporarily relieves minor pains

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a doctor before use. 

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

Directions

Inactive ingredients

camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water and xantham gum.

RollOnLabel

TOPICAL PAIN RELIEF 
lidocaine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:89076-1095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:89076-1095-760 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2018
Labeler - LEON MEDICAL CENTERS, INC (947237210)

Revised: 7/2018
Document Id: 650074eb-5820-424a-b331-037c99512360
Set id: 1198a56b-9719-41c9-9a8c-2fafe68f46c5
Version: 1
Effective Time: 20180707
 
LEON MEDICAL CENTERS, INC