Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel
- NDC Code(s): 0283-0998-45, 0283-0998-59
- 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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- Official Label (Printer Friendly)
- Active ingedient
- Purpose
- Uses
- Warnings
-
Stop use and ask doctor if
- sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting
- sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens
DO NOT USE:- if the product film is punctured or damaged
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for teething
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in children under 2 years of age
- When using this product
- Keep out of reach of children.
- Adverse Reactions:
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Directions
- do not exceed recommend 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: consult a dentist or doctor
- Other information
- Inactive ingredient
- Questions or comments?
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INGREDIENTS AND APPEARANCE
HURRICAINE TOPICAL ANESTHETIC
benzocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0283-0998 Route of Administration 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 Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0283-0998-59 60 in 1 BOX 01/31/2021 1 NDC:0283-0998-45 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 09/15/1998 Labeler - Beutlich Pharmaceuticals LLC (005209325) Registrant - Beutlich Pharmaceuticals LLC (005209325) Establishment Name Address ID/FEI Business Operations Dental Technologies 148312838 manufacture(0283-0998) Establishment Name Address ID/FEI Business Operations Centrix Inc. 053707303 label(0283-0998) Establishment Name Address ID/FEI Business Operations Beutlich Pharmaceuticals, LLC 005209325 label(0283-0998) , pack(0283-0998)