Label: BENZOCAINE- topical anesthetic spray
- NDC Code(s): 84415-044-01
- Packager: Everpharm LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 15, 2025
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- Drug Facts
- Active Ingredient
- Purpose
- INDICATIONS & USAGE
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Warnings
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)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energyAllergy 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.
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
BENZOCAINE
topical anesthetic sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84415-044 Route of Administration PERIODONTAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SUCRALOSE (UNII: 96K6UQ3ZD4) CHERRY (UNII: BUC5I9595W) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84415-044-01 25 in 1 PACKAGE 01/15/2025 1 1 in 1 POUCH 1 0.5 mL 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 Drug M022 01/15/2025 Labeler - Everpharm LLC (119288836)
