Label: HURRICAINE- topical anesthetic spray
- NDC Code(s): 0283-0610-11, 0283-0610-26, 0283-0610-43
- 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.
Updated August 27, 2019
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- Active Ingredient
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)
• 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.
- Other information
- Inactive ingredients
- Questions or comments?
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- Principal Display Panel
INGREDIENTS AND APPEARANCE
topical anesthetic spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0283-0610 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) 349 mg in 1 g SACCHARIN SODIUM (UNII: SB8ZUX40TY) 12 mg in 1 g CHERRY (UNII: BUC5I9595W) 439 mg in 1 g Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0283-0610-11 2 in 1 BOX 04/01/2016 1 NDC:0283-0610-43 0.492 g in 1 APPLICATOR; Type 0: Not a Combination Product 2 NDC:0283-0610-26 25 in 1 BOX 04/01/2016 2 NDC:0283-0610-43 0.492 g in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/15/2010 Labeler - Beutlich Pharmaceuticals LLC (005209325) Registrant - Beutlich Pharmaceuticals LLC (005209325) Establishment Name Address ID/FEI Business Operations SPECIALITY PHARMA MANUFACTURING, LLC 013957125 manufacture(0283-0610)