NDC Code(s) : 65628-050-01
Packager : CutisPharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FIRST Mouthwash BLMDiphenhydramine Hydrochloride and Lidocaine Hydrochloride and Aluminum Hydroxide and Magnesium Hydro KIT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65628-050
Route of Administration ORAL DEA Schedule
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65628-050-011 in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/01/2004

PRINCIPAL DISPLAY PANEL

NDC 65628-050-01
FIRST® Mouthwash BLM
Each kit contains:
Active Ingredients:
Diphenhydramine hydrochloride 0.2g
Lidocaine hydrochloride 1.6g
Aluminum hydroxide 3.15g in 236mL suspension (equivalent to dried gel USP)
Magnesium hydroxide 3.15g in 236mL suspension
Simethicone 0.315g in 236mL suspension
8 FL OZ (237 mL) as dispensed

PRINCIPAL DISPLAY PANEL NDC 65628-050-01 FIRST® Mouthwash BLM