Orajel Dental Gel
_1 Cfcnr.
13mm |
•t48mm
Read all of this leaflet carefully because it contains important information for you
This medicine is available without prescription. However, you still need to use Orajel Dental Gel carefully to get the best results from it
• Keep this leaflet. You may heed to read it again.
• Ask your pharmacist if you'need more information or advice. '
• You must contact a doctor Jor dentist if your symptoms worsen or go not improve.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist
Patient Information Leaflet Information for tihe user
Orajel Dental Gel
Benzocaine 10% w/w
In this leaflet:
1. What is ORAJEL DENTAL GEL and what it is used for
2. Before you use ORAJEL DENTAL GEL
3. How to use ORAJEL DENTAL GEL
4. Possible side effects
5. How to store ORAJEL DENTAL GEL
6. Further information
1. What is ORAJEL DENTAL GEL and what it is used for
The name of your medicine is'Orajel Dental Gel. It contains benzocaine at a concentration of 10% wAv. '
8enzocaine belongs to a group of medicines called local anaesthetics. It provides rapid relief by numbing the area arjd therefore reducing the pain.
Orajel Dental Gel is used to temporarily reduce the toothache pain associated with a broken tooth or in a tooth where you may require a filling.
Church & Dwight UK Ltd
2. Before you |ise ORAJEL DEKTAL GEL
Do not use Ortijel Dental Gel:
• If you have }iad an allergic reaction to benzocaine,or any of the ingredients in the gel particularly sorbic acid. An allergic reaction may include a rash, stinging, swelling or itching. This product contains soibic acid, which may cause local skin reactions (eg contact dermatrtis).i
• If you have been told by your doctor that you haw difficulty converting a component^ your blood called methaemoglobin to haemoglobin. This condition is,very rare, see section 4 for more detail^.
• In children below the age of 12 years Taking other medicines
Do not use Orajel Dental Gel if you are taking any antibiotics called sulphonamidef, for example co-trimoxazole, as benzocaine may prevent them pom working well.
Please tell your doctor, pharmacist or dentist if you are taking or have recently taken any othfer medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding If you are prednant or breast-feeding, make sure it is safe fpr you to apply Orajel Dental Gel. ,
If you are unsure, talk to your pharmacist, doctor or dentist.
iCfaniT:
Iflmm |
E
£
Each tube con Dental Gel.
ains 5.3g of Orajel
3. How to use ORAJEL DENTAL GEL
If you are unsure, you should check with your doctor, pharmacist or dentist.
Avoid taking pot drinks whilst using Orajel Dental Gel. ,
For adults and children 12 years and over, remove cap, out open tip of tube and with a clean finger apply an amount of gel the size of a green pea into the tooth cavity.
Do not use in'children below the age of 12 years. 1
You can use Orajel Dental Gel up to a maximum of 4 times a day.
Remember j
Orajel Denta^Gel is intended for short-term use until you fan get to a dentist. It should not be used cpntinuously.
If the tootharjhe persists, consult your dentist. i
If you use more Orajel Dental Gel than you should i
Contact your nearest hospital casualty department doctor or dentist immediately. Take this leaflet and any remaining gel with you to show the doctor or dentist.
4. Possible side effects
Like all medicines, Orajel Dental Gel can cause side effects, although not everybody gets them. 1 Stop using the gel and contactyour doctor or dentist immediately if any of the following occbr:
• an allergicVeaction (burning, stinging, itching and/or a rash)
• skin irritation Very rare
• a condition called methaemoglobinaemia (difficulty converting a component of your blooq called methaemoglobin to haemoglobin).
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this;
leaflet. You cah also report side effects directly via thg Yellow Card Scheme at v.v.w.mhra.gdv.uk/yellowcard: By reporting side effects, ydu can help provide more information oh the safety of this medicine.
5. How to storje ORAJEL DENTAL GEL Keep this medicine out of the reach and sight of children.
Do not use Orajel Dental Gel if the tube or pack is damaged.
Do not use Orajel Dental Gel after the expiry date which is stated on the pack.
6. Further infcjrmation
What Orajel Dental Gel contains Orajel Dental Gel contains lOty wtoof benzocaine asithe active ingredient.
Orajel Dental Gel also contains macrogol 400, polyethylene glycol 3350, sodium saccharin (E954), sorbic acid (E20O), natural spearmint flavor, citric acid and clove oil. What Orajel Dfental Gel looks like and contents of thb pack Orajel Dental uel is a colourless gel.
It smells like it in*
Marketing Authorisation Holder and Manufacturer;
The Marketing Authorisation Holder for Orajel Dental Gel is Church & Dwight UK Ltd., Premier House, Shearway Business Park, Pent Road, Folkestone, Kent CT19 4RJ Orajel is a trademark of Church & Dwight Co., Inc. i The manufacturer for Orajel Dental Gel is Laleham Health and Beauty Limited,
Mill Lane, Altdn, GU34 2PR
Is this leaflet hard to see or read? Phone 0800 028 1454 for help.
The leaflet wa^ last updated inj April 2015 MA Number: 00203/0227 SU3789P