SENSICAINE TM EXTRA TOPICAL ANESTHETIC- benzocaine gel

Sensicaine TM Extra by

Drug Labeling and Warnings

Sensicaine TM Extra by is a Otc medication manufactured, distributed, or labeled by Safco Dental Supply Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingridients (in each gram)

Benzocaine 200 mg

Purpose

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

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

• for teething
• in children under 2 years of age

WHEN USING

When using this product Avoid contact with eyes. If contact occurs, flush with water.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, consult a doctor before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

• adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve pain
• children under 2 years of age: do not use

Other information

• Store at 59 - 86ºF (15 - 30ºC).
• Protect from freezing.

Inactive ingredients

flavoring, PEG 3350, PEG 400, sucralose. May contain D&C Red #33, FD&C Red #40, D&C Green #5, FD&C Yellow #5 as a color additive.

Questions or comments?

800-621-2178

www.safcodental.com

PRINCIPAL DISPLAY PANEL - Jar Label

SAFCO
SensiCaineTM Extra

Topical Anesthetic Gel

Contains 20% Benzocaine

Mint Flavor

For Professional Use Only

1 oz. (34 g)

INGREDIENTS AND APPEARANCE

SENSICAINE TM EXTRA  TOPICAL ANESTHETIC
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67239-0213
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	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67239-0213-1	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)