FINAFTA- ethyl alcohol, salicylic acid, benzocaine liquid
Efficient Laboratories Inc.
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.
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Active Ingredients: (%) Purpose
Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic
Salicylic Acid 1% w/v.........................Anesthetic/Analgesic
Benzocaine USP 5% w/v...................Anesthetic/Analgesic
Warnings
Methemoglobinemia warning: Use of this product may cause mthemoglobinemia, a serious condition that must be treated promptyly 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:
Allegry alert
Alcogol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whehter you should take slicylic acid or other pain reliever, fever reducer. Salicylic acid may cause stomach bleeding.
Flammable: Keep away from fire or flame.
Do not use
When using this prduct Do not use near eyes. Do not prolong usage unless directed by a doctor/dentist.
Stop use and ask a doctor promptly if sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persists or worsens. If you sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.
Keep out of reach of children. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.
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 under 12 years of age should be supervised in the use of the product. Do not use in children under 2 years of age.
FINAFTA
ethyl alcohol, salicylic acid, benzocaine liquid |
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Labeler - Efficient Laboratories Inc. (969044932) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Dextrum Laboratories Inc. | 007392322 | manufacture(58593-780) |