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
Drug Label Information
Updated October 28, 2024
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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
-
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:
-
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?
- Principal Display Panel
-
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 Drug M022 09/15/1998 Labeler - Beutlich Pharmaceuticals LLC (005209325) Registrant - Beutlich Pharmaceuticals LLC (005209325) Establishment Name Address ID/FEI Business Operations Beutlich Pharmaceuticals, LLC 005209325 label(0283-0998) , pack(0283-0998) Establishment Name Address ID/FEI Business Operations Centrix Inc. 053707303 label(0283-0998) Establishment Name Address ID/FEI Business Operations Dental Technologies 148312838 manufacture(0283-0998)


