SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL- benzocaine gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Benzocaine 200mg (in each g)
Available from:
Safco Dental Supply Co.
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Oral Anesthetic For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Authorization status:
OTC monograph not final
Authorization number:
67239-0221-1

SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL- benzocaine gel

Safco Dental Supply Co.

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.

----------

Active Ingredients

Benzocaine 200mg (in each g)

Purpos e

Oral Anesthetic

Us e

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 the 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 procaine,

butacaine, benzocaine or other "caine" anesthetics.

Do not use

for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7

days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see

your physician promptly.

for teething

in children under 2 years of age

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

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get

medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a physician before use.

Keep out of reach of children.

Directions

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°-86°F (15°-30°C). Protect from freezing.

Inactive ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red

#28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Questions or comments?

safcodental.com * 1-800-621-2178

SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL

benzocaine gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7239 -0 221

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

20 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

FD&C RED NO . 3 (UNII: PN2ZH5LOQY)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

D&C GREEN NO . 5 (UNII: 8 J6 RDU8 L9 X)

Product Characteristics

Color

ye llo w

S core

S hap e

S iz e

Flavor

PINEAPPLE (Pina Co lada)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7239 -0 221-1

30 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 5/20 19

Safco Dental Supply Co.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 3/0 5/20 19

Labeler -

Safco Dental Supply Co. (020417380)

Revised: 9/2019

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