OTC Medication Information: HurriCaine Topical Anesthetic Gel

HURRICAINE TOPICAL ANESTHETIC GEL- benzocaine gel
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.

Active ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

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 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, 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.

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
• if product film is punctured or damaged
• for teething
• in children under 2 years of age

When using this product

When using this product: avoid contact with eyes

Keep out of reach of children

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

adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then spit out. 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

Storage and Handling

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

flavor, polyethylene glycol, sodium saccharin

Questions or comments?

1-800-238-8542
M-F: 8:00 a.m. to 4:30 p.m. ET

Principal Display Panel

unit dose gel Pina Colada
(click image for full-size original)

HurriCaine Unit Dose Gel Pina Colada 0.5g with Swab: 0283-0886-45

60ct HurriCaine Unit Dose Gel Pina Colada 0.5g with Swab: 0283-0886-59

60ct box unit dose gel Pina Colada
(click image for full-size original)
HURRICAINE TOPICAL ANESTHETIC GEL
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0283-0886
Route of Administration ORAL, DENTAL, PERIODONTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM
Product Characteristics
Color yellow (yellow to pale orange) Score
Shape Size
Flavor COCONUT (Pina Colada Flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0283-0886-59 60 CUP, UNIT-DOSE in 1 BOX contains a CUP, UNIT-DOSE (0283-0886-45)
1 NDC:0283-0886-45 0.5 g in 1 CUP, UNIT-DOSE This package is contained within the BOX (0283-0886-59)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 08/15/1986
Labeler — Beutlich Pharmaceuticals, LLC (005209325)
Registrant — Beutlich Pharmaceuticals, LLC (005209325)
Establishment
Name Address ID/FEI Operations
Dental Technologies, Inc. 148312838 manufacture (0283-0886)
Establishment
Name Address ID/FEI Operations
Centrix Inc 053707303 label (0283-0886)
Establishment
Name Address ID/FEI Operations
Beutlich Pharmaceuticals, LLC 005209325 label (0283-0886), pack (0283-0886)

Revised: 03/2023 Beutlich Pharmaceuticals, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.