FDA Label for Topicale
View Indications, Usage & Precautions
Topicale Product Label
The following document was submitted to the FDA by the labeler of this product Medical Products Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Benzocaine 18%
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 lightheadedness, fatigue or lack of energy.
- Do not use for Teething
- Do not use in children under 2 years of age
- Do not use in large quantities or over large areas of body
- Avoid contact with eyes
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
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
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
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, D&C Red Dye # 33 (Cherry & Raspberry), FD&C Red Dye # 40 (Strawberry), Flavorings, Polyethylene glycol, Purified Water, Saccharin sodium.
Information For Owners/Caregivers
Premier
Topicale
Topical Anestheic Gel
REF
9007141 Cherry
9007142 Raspberry
9007143 Strawberry
9007144 Pina Colada
9007140 Assorted
Made in U.S.A.
Contents: Three 43g Pumps
0518001 Rev4 MPL 317935
Retain drug facts for future reference.​
Manufactured for: Premier® Dental Products Company,
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A.
Manufacturer: Medical Products Laboratories, Inc.
9990 Global Road Philadelphia, PA 19115 U.S.A.
Questions or Comments?
888.670.6100 or 610.239.6000
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To obtain an SDS, contact Customer Service Department or visit www.premusa.com.
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