Iodent Oral Analgesic Gel 0.42 Oz 490 (zdp)

Iodent Oral Analgesic Gel 0.42 Oz 490 (zdp)
SPL v8
SPL
SPL Set ID 63902125-f8dc-0ada-e053-2991aa0a7ce5
Route
TOPICAL
Published
Effective Date 2018-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Saccharin Sorbitol Glycerin Peppermint Polyethylene Glycol 400 Polyethylene Glycol 4000

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-02
Description

Active ingredient Purpose Benzocaine 20%............................................Oral Pain Reliever

Medication Information

Warnings and Precautions

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 energy

Allergy Alert: do not use this product if your child has a history of allergy or local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Indications and Usage

Directions

Adults and children 2 years of age and older. Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. 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. Do not use.

Dosage and Administration

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

1-800-814-8028

Made in China

Description

Active ingredient Purpose Benzocaine 20%............................................Oral Pain Reliever

Section 44425-7

Other information

  • store at room temperature 20° to 25°C (68° to 77°)
  • this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist or doctor can be consulted
  • do not use continuously
Section 50565-1

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness does not go away
  • swelling, rash or fever develops
Section 50570-1

Do not use

  • more than directed
  • for more than 7 days unless directed by a doctor
  • for teething
  • in children under 2 years of age
Section 51727-6

Inactive ingredients

glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

for the temporary relief of pain due to:

  • toothache
  • canker sores
  • gum pain
  • denture pain
  • cheek bites
Section 55106-9

Active ingredient Purpose

Benzocaine 20%............................................Oral Pain Reliever

Structured Label Content

Indications and Usage (34067-9)

Directions

Adults and children 2 years of age and older. Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. 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. Do not use.

Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

1-800-814-8028

Made in China

Warnings and Precautions (34071-1)

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 energy

Allergy Alert: do not use this product if your child has a history of allergy or local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20° to 25°C (68° to 77°)
  • this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist or doctor can be consulted
  • do not use continuously
Section 50565-1 (50565-1)

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness does not go away
  • swelling, rash or fever develops
Section 50570-1 (50570-1)

Do not use

  • more than directed
  • for more than 7 days unless directed by a doctor
  • for teething
  • in children under 2 years of age
Section 51727-6 (51727-6)

Inactive ingredients

glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

for the temporary relief of pain due to:

  • toothache
  • canker sores
  • gum pain
  • denture pain
  • cheek bites
Section 55106-9 (55106-9)

Active ingredient Purpose

Benzocaine 20%............................................Oral Pain Reliever

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:48.415418 · Updated: 2026-03-14T23:13:18.140905