TOPICALE- benzocaine ointment
Medical Products Laboratories, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
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 lightheadedness, fatigue or lack of energy.
Contraindications:
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
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
Benzalkonium Chloride (as a preservative), Cetyl Alcohol, Flavorings, Polyethylene glycol, Propylene glycol, Saccharin sodium.
NDC 10733-162-35
Premier
Topicale
Topical Anesthetic Ointment
Benzocaine, 18 %
REF 9007151 35g Jar
Orange-Raspberry
Made in U.S.A.
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.
0518003 Rev4 MPL 317929
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 www.premusa.com.
Retain drug facts for future reference.
TOPICALE
benzocaine ointment |
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Labeler - Medical Products Laboratories, Inc. (002290302) |