Care Intensive Drug MF# MF-001

pharmaceutical company
Rev # 1
Implementation /effective
Title Master /Batch Formula 23/4/2020
Date
Page # 1 of 1

Product Name: Xylocaine 2% jelly® (Lidocaine HCl 2% jelly)

Dosage Form/ 20 mg in 1 g Product Code NDC17478-811
strength
Batch Size 20,000 tubes Shelf Life 24 months
Weight/ unit 30 g Date: 22/4/2020
Issued by (Q.A.)

Code Component Function Quantity Quantity Quantity Ref

(%) /unit (g) /batch (kg)
A017 Lidocaine HCL Active 2% 0.6 12 USP
ingredient
E045 Hydroxypropyl thickening 3% 0.9 18 USP
methylcellulose agent
E013 Methylparaben Antimicrobial 0.18% 0.054 1.08 USP
preservative
E014 Propylparaben Antimicrobial 0.02% 0.006 0.12 USP
preservative
E072 Sodium pH adjustment 0.3% 0.09 1.8 USP
Hydroxide
E071 Hydrochloric acid pH adjustment 0.02% 0.006 0.12 USP
E002 Purified Water, Dispersion 94.46% 28.344 566.88 USP
USP medium

Prepared By Ahmad Checked by Mohammad Approved By Rami

Date 22/4/2020 Date 22/4/2020 Date 22/4/2020