Topicale Xtra
Benzocaine · Gel · Oral
Active ingredient
Benzocaine 20%
Purpose
Oral Anesthetic
Uses
For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops pale, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or light headedness, fatigue or lack of energy. Contraindications: Do not use in large quantities or over large areas of body Do not use for Teething Do not use in children under 2 years of age Allergy Alert: Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics When using this product Avoid contact with eyes In case of accidental overdose, get medical help or contact a Poison Control Centre immediately. Stop use and ask a doctor If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
Ask a doctor before use
Stop use and ask a doctor If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
Keep out of reach of children
In case of accidental overdose, get medical help or contact a Poison Control Centre immediately.
Directions
Do not use more than directed. Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children 2-12 years of age - Should be supervised in the use of the product. Children under 2 years of age - Do not use.
Inactive ingredients
Benzalkonium Chloride (as a preservative), Carbomers, D&C Red Dye # 33, Flavorings, Polyethylene Glycol, Purified Water, Saccharin Sodium
Label text from the FDA structured product label by Medical Products Laboratories,Inc. (revised Dec 16, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Benzocaine in 3 products
Topicale Xtra NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 10733-175 | Benzocaine 200 mg/g Gel | Medical Products Laboratories, Inc. | OTC MONOGRAPH DRUG |
| 10733-174 | Benzocaine 200 mg/g Gel | Medical Products Laboratories,Inc. | OTC MONOGRAPH DRUG |
| 10733-176 | Benzocaine 200 mg/g Gel | Medical Products Laboratories,Inc. | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Topicale Xtra used for?
For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Who makes Topicale Xtra?
Topicale Xtra is listed by 2 labelers in the FDA NDC directory, including Medical Products Laboratories, Inc., Medical Products Laboratories,Inc..