LIDOCAINE HYDROCHLORIDE VISCOUS- lidocaine hydrochloride gel 
TRUE FIT RX LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Lidocaine Label 20mL cup

Lidocaine Label_pg1Lidocaine Label_pg2

DELIVERS 20 ML

LIDOCAINE HYDROCHLORIDE  VISCOUS
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69938-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN (UNII: FST467XS7D)  
ORANGE (UNII: 5EVU04N5QU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69938-101-1120 mL in 1 CUP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/06/2015
Labeler - TRUE FIT RX LLC (079868455)
Registrant - TRUE FIT RX LLC (079868455)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Pharmacal - an Akorn Company869019794manufacture(69938-101)

Revised: 7/2015
Document Id: fea57051-9594-4de6-81a3-519d3feb8efb
Set id: 9ff35525-9c92-40a3-b3e6-bee3f85ba786
Version: 1
Effective Time: 20150706
 
TRUE FIT RX LLC