Label: HURRICAINE TOPICAL ANESTHETIC GEL- benzocaine gel
- NDC Code(s): 0283-0293-45, 0283-0293-59
- Packager: Beutlich Pharmaceuticals, LLC
- 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 March 2, 2023
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- Active ingredient
- Purpose
- Uses
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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 energyAllergy 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
- When using this product
- Keep out of reach of children
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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
- Other information
- Inactive ingredient
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INGREDIENTS AND APPEARANCE
HURRICAINE TOPICAL ANESTHETIC GEL
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0283-0293 Route of Administration ORAL, DENTAL, PERIODONTAL 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 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color white (colorless) Score Shape Size Flavor WATERMELON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0283-0293-59 60 in 1 BOX 01/31/2021 1 NDC:0283-0293-45 0.5 g in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/15/1993 Labeler - Beutlich Pharmaceuticals, LLC (005209325) Establishment Name Address ID/FEI Business Operations Dental Technologies Inc. 148312838 manufacture(0283-0293) Establishment Name Address ID/FEI Business Operations Centrix Inc 053707303 label(0283-0293) Establishment Name Address ID/FEI Business Operations Beutlich Pharmaceuticals, LLC 005209325 label(0283-0293) , pack(0283-0293)
