Otc - Active Ingredient
Benzocaine 20%
Topicale Xtra Gel
FDA Label NDC 10733-175
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medical Products Laboratories, Inc. for the product Topicale Xtra (NDC 10733-175). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - ask doctor, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral Anesthetic
Indications & Usage
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
Otc - Keep Out Of Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Centre immediately.
Otc - Ask Doctor
Stop use and ask a doctor
1. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting
2. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens
Dosage & Administration
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.
Other Safety Information
Do not use if imprinted seal under cap is broken or missing
Store at 68° to 77° F (20° - 25° C)
Inactive Ingredient
Benzalkonium Chloride (as a preservative), Carbomers, FD&C Blue Dye # 1, FD&C Yellow Dye # 5, Flavorings, Polyethylene Glycol, Purified Water, Saccharin Sodium
Information For Owners/Caregivers
Peel for Drug Facts
NDC 10733-175-01
Premier
Topicale Xtra
Topical Anesthetic Gel
Benzocaine, 20 %
REF 9007153 Mint Freeze 28.35g (1 o.z.)
For Topical Use only - Not for Injection
Contains: 20 % Benzocaine in a specially designed glycol base
Made in U.S.A.
premierdentalco.com
Manufactured for: Premier® Dental Products Company,
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A.
Mfg: Medical Products Laboratories, Inc.
9990 Global Road Philadelphia, PA 19115 U.S.A.
1120048 MPL Rev5 . 2000265(00)
Questions or Comments?
888.670.6100 or 610.239.6000
M-Th: 7:30a.m. - 5:30p.m., F: 7:30a.m. - 4:00p.m. EST
To obtain an SDS, contact Customer Service Department or visit premierdentalco.com.
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