HURRICAINE TOPICAL ANESTHETIC- benzocaine spray

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

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Active ingredient:
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)
Available from:
Beutlich Pharmaceuticals, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Oral Anesthetic for the temporary relief of occasional minor irritation and pain, associated with: - canker sores - sore mouth and throat - minor injury of the mouth and gums - minor dental proedures - minor irritation of the mouth and gums caused by dentures or orthodontic appliances Do not use • for teething • in children under 2 years of age
Authorization status:
OTC monograph not final
Authorization number:
0283-0914-02

HURRICAINE TOPICAL ANESTHETIC- benzocaine spray

Beutlich Pharmaceuticals, LLC

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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Drug Facts

Active ingredient

Benzocaine 20%

Purpos e

Oral Anesthetic

Us es

for the temporary relief of occasional minor irritation and pain, associated with:

canker sores

sore mouth and throat

minor injury of the mouth and gums

minor dental proedures

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, 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 if you have a history of allergy to local anesthetics such as procaine,

butacaine, benzocaine or other "caine" anesthetics.

Flammable. Do not use near fire or flame. Avoid smoking during use.

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 irritation, pain, or redness persists or worsens, see your

dentist or doctor promptly.

Do not use

Do not use

for teething

in children under 2 years of age

When using this product

When using this product

avoid spraying in eyes

do not store at temperature above 49 °C (120 °F)

do not puncture or incinerate. Contents under pressure.

use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be

harmful or fatal.

Keep out of reach of children.

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control

Center immediately.

Directions

Directions :

do not exceed recommended dosage

firmly insert extension tube into spray can valve and ensure it fits securely into the actuator opening

position the extension tube 1-2 inches from the affected area

spray 1/2 second (press and immediately release actuator)

repeat once if necessary

anesthesia is accomplished in approximately 20 seconds

adults and children 2 years of age and older: Use up to 4 times daily or as directed by a dentist or

doctor.

children under 12 years of age: should be supervised in the use of the product.

children under 2 years of age: do not use

Inactive ingredients

flavor, hydrocarbon propellant (isobutane and propane), polyethylene glycol, sodium saccharin

Questions or comments?

1-800-238-8542

M-F: 8:00 a.m. - 4:30 p.m. ET

Principal Display Panel

Cool Mint Spray NDC 0283-0914-02

HURRICAINE TOPICAL ANESTHETIC

benzocaine spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 28 3-0 9 14

Route of Administration

ORAL, DENTAL, PERIODONTAL

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 4 0 0 (UNII: B6 9 78 9 4SGQ)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

MINT (UNII: FV9 8 Z8 GITP)

Beutlich Pharmaceuticals, LLC

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 28 3-0 9 14-0 2

59 .7 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 14

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 9 /0 1/20 14

Labeler -

Beutlich Pharmaceuticals, LLC (005209325)

Registrant -

Beutlich Pharmaceuticals, LLC (005209325)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Precise Packaging, LLC

19 43259 9 9

ma nufa c ture (0 28 3-0 9 14)

Revised: 6/2020

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