After the application of EMLA cream to intact male genital skin for 15 minutes
(median 1 g), plasma concentrations of lidocaine and prilocaine (mean 6.6 nanogram/
ml and 4.1 nanogram/ml) were reached after approximately 1.5 hours.
After application to the thigh in adults (60 g cream/400 cm2 for 3 hours) the extent
of absorption was approximately 5% of lidocaine and prilocaine. Maximum plasma
concentrations (mean 0.12 and 0.07 micrograms/ml) were reached approximately
2-6 hours after the application.
The extent of systemic absorption was approximately 10% following application to
the face (10 g/100 cm2 for 2 hours). Maximum plasma levels (mean 0.16 and 0.06
micrograms /ml) were reached after approximately 1.5-3 hours.
Genital mucosa: Absorption from the genital mucosa is more rapid than after
application to the skin. After the application of 10 g EMLA Cream for 10 minutes to
vaginal mucosa maximum plasma concentrations of lidocaine and prilocaine
(mean 0.18 micrograms /ml and 0.15 micrograms/ml respectively) were reached after
5.3 Preclinical safety data
Lidocaine and prilocaine are well established active ingredients.
6. Pharmaceutical Particulars
6.1 List of excipients
Polyoxyethylene hydrogenated castor oil, Carbomer 974P, sodium hydroxide and
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 30°C, do not freeze.
6.5 Nature and contents of container
‘Pre-medication pack’ containing 5 x 5 g tubes EMLA and 12 occlusive dressings.
Pack containing 10 x 5 g tubes of EMLA.
1 x 30 g tube with enclosed spatula.
1 x 5 g tube.
6.6 Special precautions for disposal and other handling
1. Name of the Medicinal Product
EMLA™ Cream 5%
2. Qualitative and Quantitative composition
Lidocaine 2.5% w/w (25 mg/g)
Prilocaine 2.5% w/w (25 mg/g)
For excipients, see 6.1.
3. Pharmaceutical Form
White soft cream.
4. clinical Particulars
4.1 Therapeutic indicat