Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel
- NDC Code(s): 0283-0998-31, 0283-0998-43
- 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 January 8, 2020
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- Active ingedient
- Stop use and ask doctor if
- When using this product
- Keep out of reach of children.
- Adverse Reactions:
- 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
Product 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:0283-0998-31 28.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/1998 2 NDC:0283-0998-43 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 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 Speciality Pharma Manufacturing 013957125 manufacture(0283-0998)