Orthotown September 2020 - 45

Fig. 2: Topical compound formula.

Active

Drug Name

NDC

Manufacturer

Net

AWP

Quantity

Unit

**

Lidocaine, USP

38779008109

MEDISCA

1.62

45.58

10.66100

Gm

**

Prilocaine hydrochloride, USP

38779015504

MEDISCA

13.60

285.00

10.00000

Gm

**

Tetracaine HCL powder, USP

38779056604

MEDISCA

2.88

26.75

4.00000

Cap

**

Phenylephrine HCL, USP

38779024704

MEDISCA

2.36

62.70

2.00000

Gm

**

Stevioside powder

38779193004

MEDISCA

0.36

2.99

0.60000

Gm

**

Acesulfane potassium, NF

38779259005

MEDISCA

0.35

3.59

0.60000

Gm

**

Magnasweet powder 135

51927262900

PCCA

0.18

0.36

0.20000

Gm

**

Bitter Stop liquid flavor

51927351900

PCCA

0.24

1.32

0.50000

Ml

Peppermint oil

38779082704

MEDISCA

0.10

0.53

0.20000

Ml

**

Spearmint oil flavor

51927117800

PCCA

0.31

0.87

0.20000

Ml

**

Polysorbate Sol 20

51927105400

PCCA

0.26

0.51

0.50000

Ml

**

Food color, Blue liquid

-----------

-------

0.03

0.03

0.10000

Ml

**

Hydoxythehyl cellulose, NF (4500-6500) CPS

38779210105

MEDISCA

0.75

4.16

3.00000

Gm

**

C-Preserved water (Parabens)

-----------

-------

1.56

3.94 100.00000

Ml

Compounding Notes
RX
Initials
Date
Note: This formula was developed using Hydroxyethyl Cellulose NF (4500-6500 CPS, 2%, 25C) Lot # C128082. A 2% solution of this
lot has the viscosity of 4940 CPS. Since the viscosity of hydroxyethyl cellulose may vary from lot to lot, the amount of hydroxyethyl
cellulose in this formula may be adjusted between 2-3% to achieve a desired consistency.
1. In an appropriate size container, dissolve lidocaine
hydrochloride monohydrate, phenylephrine hydrochloride,
prilocaine hydrochloride and tetracaine hydrochloride
in preserved water (Parabens) (USP <51> study). Use an
amount of preserved water (Parabens)(USP <51> study) that
is approximately 60% of the final volume. For example, if
the final volume is 100 mL, use 60 mL of preserved water
(Parabens)(USP <51> study).

3. Add and dissolve steviol glycosides 95%, acesulfame
potassium and Magnasweet 135 in step 2.

2. Check the pH of step 1 with a pH meter. Adjust the pH to 5-6
by adding sodium hydroxide 5% (W/V) aqueous solution to
make pH higher dropwise or hydrochloric acid 1% to lower
pH. Mix thoroughly and check to pH after each addition. Only
several drops of sodium hydroxide 5% (W/V) aqueous solution
may be required for each 100mL of final preparation in this
step, so be patient and avoid adding too much.

6. Add hydroxyethyl cellulouse to step 5 while mixing. The
use of a strainer helps to ensure small particle size. While
mixing, bring to final volume with preserved water (Parabens)
(USP <51> study) and continue to mix until a viscous
liquid is formed and too thick to stir. Let it stand until the
hydroxyethyl cellulose is fully hydrated and a smooth gel is
obtained.

4. Add polysorbate 20, spearmint oil, peppermint oil and PCCA
Bitter Stop (The Mask Suppressor) flavor to step 3 and mix
thoroughly.
5. Add food color to step 4 and mix thoroughly.

Note: Protect from light. Do not store in metal containers. Store in airtight containers. BUD 30 days (9849) PCCA

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