Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel
- NDC Code(s): 0283-1820-34, 0283-1820-43
- Packager: Beutlich Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 1, 2023
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- Active ingredient
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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 dosageadults 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
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INGREDIENTS AND APPEARANCE
HURRICAINE TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0283-1820 Route of Administration DENTAL, PERIODONTAL, ORAL 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 yellow (yellow to pale orange) Score Shape Size Flavor COCONUT (Pina Colada Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0283-1820-34 4 in 1 TRAY 07/01/2023 03/31/2026 1 NDC:0283-1820-43 1.5 g in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 02/28/2021 Labeler - Beutlich Pharmaceuticals, LLC (005209325) Registrant - Beutlich Pharmaceuticals, LLC (005209325)