Label: SENSICAINE TM EXTRA TOPICAL ANESTHETIC- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 67239-0212-1 - Packager: Safco Dental Supply Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 11, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingridients (in each gram)
- Purpose
- Use
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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, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Allergy alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
Sore throat warning:If sore throat is severe,persists for more than 2 days,is accompanied or followed by fever, headache, rash, swelling, nausea,or vomiting, consult a doctor promptly.If sore mouth symptoms do not improve in 7 days, or if irritation,pain, or redness persist or worsen, see your dentist or doctor promptly.
- Do not use
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - Jar Label
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INGREDIENTS AND APPEARANCE
SENSICAINE TM EXTRA TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67239-0212 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 200 mg in 1 g Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 (UNII: G2M7P15E5P) Polyethylene Glycol 400 (UNII: B697894SGQ) Sucralose (UNII: 96K6UQ3ZD4) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67239-0212-1 29 g in 1 JAR; Type 0: Not a Combination Product 04/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 04/30/2017 Labeler - Safco Dental Supply Co. (020417380) Registrant - Safco Dental Supply Co. (020417380)