Label: FINAFTA- benzocaine, glycerin liquid
- NDC Code(s): 58593-783-15
- Packager: Efficient Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 27, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not exceed recommended dosage
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 the 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 energy
Allergy alert
- do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
•adults and children over 12 years of age apply to the affected area, mouth, gums or mucous membrane with the applicator provided, up to 4 times daily or as directed by a dentist or doctor. Remain in place at least 1 minute and then spit out. Do not rinse mouth after each use • Children between 2 and 12 years of age: consult a doctor •children under 12 years of age should be supervised in the use of the product •do not use in children under 2 years of age.
- QUESTIONS
- INACTIVE INGREDIENT
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FINAFTA
benzocaine, glycerin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-783 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 33 mg in 100 mL BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 mg in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) PHOSPHORIC ACID (UNII: E4GA8884NN) MENTHOL (UNII: L7T10EIP3A) SUCRALOSE (UNII: 96K6UQ3ZD4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-783-15 15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 09/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 09/15/2023 Labeler - Efficient Laboratories Inc. (969044932)