Orajel Extra Strength
ICfcnnt J
18mm |
148mm
Patient Information Leaflet Information for tihe user
Orajel Extra Strength
Benzocaine 20% w/w
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 Extra Strength carefully to get the best results from it.
• Keep this leaflet You may need to read it again.
• Ask your pharmacist if you'need more information or advice. 1
• 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._____»______
In this leaflet;
1. What is ORAJEL EXTRA STRENGTH and what it is used for
2. Before you use ORAJEL EXTRA STRENGTH
3. How to use ORAJEL EXTRA STRENGTH A. Possible side effects
5. How to store ORAJEL EXTRA STRENGTH
6. Further information
1. What is ORAJEL EXTRA STRENGTH and what it is used for i
The name of your medicine is'Orajel Extra Strength. It contains benzocaine at a concentration of 20% wAv. '
8enzocaine belongs to a grogp of medicines called local anaesthetics. It provides rapid relief by numbing the area arjd therefore reducing the pain.
Orajel Extra Strength is used to temporarily reduce the toothache pain associated with a broken tooth or in a tooth where you may requires filling.
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Church & Dwight UK Ltd
2. Before you t)se ORAJEl EXTRA STRENGTH
Do not use Ortijel Extra Strength:
• 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 dermatitis}.i
• If you have been told by your doctor that you haw difficulty converting a component,of 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 Extra Strength if you are taking any antibiotics called sulphonamide}, 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 Extra Strength. ,
If you are unsure, talk to your pharmacist, doctor or dentist.
ffease fumcrrer
iCfaniT:
Iflmm |
74mm
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3. How to use ORAJEL EXTRA STRENGTH
If you are unsure, you should check with your doctor, pharmacist or dentist.
Avoid taking not drinks whilst using Orajel Extra Strength.
For adults and children 12 years and over, remove cap, out open tip of tube and with a dean 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 tyajel Extra Strength up to a maximum of *1 times a day.
Remember ,
Orajel Extra Strength is intended for short-term use until you can get to a dentist. It should not be used continuously. If the toothache persists, consult your dentist. i
If you use more Orajel Extra Strength than you should 1
Contact your hearest 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 Extra Strength can cause side effects, although not everybody gets them.
Stop using the gel and contact vour doctor or dentist imrtiediately if any or the following occbr:
• an allergic Veaction (burning, stinging, itching and/or a rash) 1
• 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;
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leaflet. You cafri also report side effects directly via thg Yellow Card Scheme at ww.mhra.gdv.uk/yellowcard.1 By reporting side effects, ydu can help provide more information oh the safety of this medicine.
5. How to storje ORAJEL EXTRA STRENGTH Keep this medjdne out of the reach and sight of children.
Do not use Orajel Extra Strength if the tube or pack is damaged.
Do not use Orajel Extra Strength after the expiry date which is stated on the pack.
6. Further information
What Orajel Eftra Strength contains Orajel Extra St/ength contains 20 W wtoof benzocaine asithe active ingredient.
Orajel Extra Strength also contains macrogol 400/ polyethylene glycol 3350, sodium saccharin (E954), sorbid acid (E200), natural spearrhint flavor, citric'add and clove oil. 1
What Orajel Ektra Strength looks like and
contents of thb pack
Orajel Extra Strength is a colourless gel.
It smells like iqint.
Each tube contains 5.3g of Orajel Extra Strength. i
Marketing Authorisation Holder and Manufacturer'
The Marketing Authorisation Holder for Orajel Extra Strength is Church & Dwight UK Ltd., Premifer House, Shearway Business Park, Pent Rosjd, Folkestone, Kjznt CT19 4RJ Orajel is a trademark of Church & Dwight Co., Inc.
The manufacturer for Orajel Extra Strength is Laleham Health and Beauty Limited,
Mill Lane, Alton, GU342PR
Is this leaflet hard to see or read’ Phone 0800 028 1454 for help.
The leaflet was last updated in April 2015 MA Number: 00203/0228 SU3790P