Active Ingredient
Benzocaine, 20%
Avant Gel
FDA Label NDC 53045-147
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dharma Research, Inc. for the product Avant (NDC 53045-147). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - do not use, warnings and precautions, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral anesthetic
Uses
For the temporary relief of pain associated with canker sores and minor dental procedures.
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 the blood. This can occur even if you have used this product before.
Stop use and seek 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
Otc - Do Not Use
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 a 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.
Warnings And Precautions
Do not exceed recommended dosage.
Otc - Keep Out Of Reach Of Children
Keep Out of Reach of Children. If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control center right away.
Directions
- Adults and children 2 years of age and older: Apply to the affected area. 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 this product
- Children under 2 years of age: Consult a dentist or doctor.
Other Information
Store at room temperature 59-86°F (15-30°C). Protect from freezing and heat.
Inactive Ingredients
FD&C Red #40, FD&C Blue #1, FD&C Yellow #6, FD&C Yellow #5, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol
Avant Oral Anesthetic Gel
Gluten Free
with 20% Benzocaine, Xylitol & Vitamin E
1.12 oz (32 g)
Pina Colada
Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166
1-877-833-3725
www.avant-dental.com
20201027_53045_147 (20201027 53045 147)
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