Calamine lotion Batch quantity 1000ml Master manufacturing formula

approved by
Prepared by:
Preparation date: Source master manufacturing
Batch number: formula: Dermatological preparations
for the tropics, 2nd ed. (modified from
BP)

Raw materials and packaging materials

Quantity Source and Actual quantity Initials weighing Initials control
prescribed batch number weighed/measured
Zinc oxide 200 g
Bentonite 30 g
Trisodium citrate (.2H2O) 5g
Glycerine 50 ml
Liquefied phenol 5 ml
Water to 1000 ml

Dark coloured glass

bottle of 1000 ml 1

Preparation In-process checks

1. Boil 1000 ml water for 1 minute and allow to cool. Use this water for the preparation. Water boiled? yes/no
2. Calibrate the glass bottle for 1000 ml. Calibration control
3. Dissolve the trisodium citrate in 700 ml of the water. Completely dissolved? yes/no
4. Mix the zinc oxide with the bentonite in a mortar.
5. Triturate this zinc oxide/bentonite mixture carefully with the glycerine and 200 ml of the citrate
solution.
6. Add the rest of the citrate solution and mix until homogeneous. Homogeneous? yes/no
7. Add the liquefied phenol and mix.
8. Put the mixture in the calibrated bottle.
9. Rinse the mortar with a little water and add to the calibrated bottle.
10. Add sufficient water to produce 1000 ml lotion. Final volume: ml
11. Close the bottle properly and mix until homogeneous. Homogeneous? yes/no

2012 jfmamjjasond 2013 jfmamjjasond 2014 jfmamjjasond 2015 jfmamjjasond 2016 jfmamjjasond 2017 jfmamjjasond

Storage condition: below 40 °C Yield

protect from direct sunlight
Shelf life: 3 months Loss
Expiry date Loss due to

End controls before release of batch Checked by Result

Batch numbers raw materials correct?
Packaging materials correct, in good condition and closed properly?
Labelling conform model label for stock?
Expiry date stated correctly?
Bottle closed properly?
Lotion homogeneous?
Are all boxes of this form filled correctly and completely?

Batch released by (name and signature) Date:

Model of label for stock Model of label for the patient

For external use only For external use only
Calamine lotion Dispensing unit and date
Batch number and batch date Calamine lotion ml
Do not use past: (production date + 3 months) Patient name
Storage below 40 °C, protect from direct sunlight Shake well before use. Paint the lotion on the skin times
Shake well before dispensing. daily and allow to dry. Do not cover.
Do not use past (dispensing date + 1 month)