DOLOGESIC ROLL-ON- lidocaine hcl liquid 
Llorens Pharmaceutical International Division, 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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Active Ingredient

Lidocaine HCL, USP 4% 

Purpose

Topical Anesthetic

Use

Temporarily relieves minor pains

Warnings

For external use only

Do not use

When using this product

Stop use and ask 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.

Questions

Llorens Pharmaceutical International Division, Inc.

Miami Fl 33147

DologesicRollOn

DOLOGESIC ROLL-ON 
lidocaine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-513
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
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:54859-513-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2018
Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)

Revised: 12/2020
Document Id: 4eddf947-9d0c-4e2c-968c-a948f7694681
Set id: 81546810-85a8-45fe-b9e6-cdd02cc4c080
Version: 2
Effective Time: 20201223
 
Llorens Pharmaceutical International Division, Inc.