Label: HURRICAINE TOPICAL ANESTHETIC GEL- benzocaine gel
- NDC Code(s): 0283-0886-31, 0283-0886-43
- 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 December 24, 2019
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- Active ingredient
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)
• 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
- When using this product
- Keep out of reach of children
• 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
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
HURRICAINE TOPICAL ANESTHETIC GEL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0283-0886 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 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:0283-0886-31 28.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/15/1986 2 NDC:0283-0886-43 1 g in 1 PACKET; Type 0: Not a Combination Product 01/28/2020 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 Business Operations Dental Technologies, Inc. 148312838 manufacture(0283-0886) Establishment Name Address ID/FEI Business Operations Speciality Pharma Manufacturing 013957125 manufacture(0283-0886)