LIDOCAINE HYDROCHLORIDE VISCOUS- lidocaine hydrochloride gel

LIDOCAINE HYDROCHLORIDE by

Drug Labeling and Warnings

LIDOCAINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by TRUE FIT RX LLC, Hi-Tech Pharmacal - an Akorn Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

DOSAGE & ADMINISTRATION

DELIVERS 20 ML

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE  VISCOUS
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69938-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69938-101-11	20 mL in 1 CUP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/06/2015

Labeler - TRUE FIT RX LLC (079868455)

Registrant - TRUE FIT RX LLC (079868455)

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal - an Akorn Company		869019794	manufacture(69938-101)