SPL v2
SPL
SPL Set ID cad932e5-8d7f-4f20-b1c2-febd328152f0
Route
DENTAL
Published
Effective Date 2023-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (6.4 g)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Blue No. 1 Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium .alpha.-tocopherol Acetate Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-22

Description

Benzocaine, 20%

Purpose

Oral anesthetic


Medication Information

Purpose

Oral anesthetic

Description

Benzocaine, 20%

Uses

For the temporary relief of pain associated with canker sores and minor dental procedures.

Section 43685-7

Do not exceed recommended dosage.

Section 50565-1

Keep Out of Reach of Children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control center right away.

Section 50570-1

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.

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

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.
Active Ingredient

Benzocaine, 20%

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, 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)

Mint

Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166

1-877-833-3725

www.avant-dental.com


Structured Label Content

Uses

For the temporary relief of pain associated with canker sores and minor dental procedures.

Section 43685-7 (43685-7)

Do not exceed recommended dosage.

Section 50565-1 (50565-1)

Keep Out of Reach of Children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control center right away.

Section 50570-1 (50570-1)

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.

Purpose

Oral anesthetic

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

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.
Active Ingredient

Benzocaine, 20%

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, 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)

Mint

Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166

1-877-833-3725

www.avant-dental.com


Advanced Ingredient Data


Raw Label Data

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