SPL v1
SPL
SPL Set ID f1908054-8527-421a-a023-0476a71c9691
Route
TOPICAL
Published
Effective Date 2012-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (0.2 g)
Inactive Ingredients
Glycyrrhizin, Ammoniated Polyethylene Glycols Saccharin Sodium Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-06-10

Description

Active Ingredient Benzocaine 20%


Medication Information

Warnings and Precautions

Warnings

  • do not use for more than 7 days unless directed by a dentist or a doctor
  • if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
Indications and Usage

Uses

for the temporary relief of pain associated with:

  • toothache
  • canker sores
  • cold sores
  • fever blisters
  • minor dental procedures
Dosage and Administration

Directions

adults and children 2 years of age and older:

  • break seal on tube
  • apply to the affected area up to 4 times daily or as directed by a dentist or a doctor
  • children under 12 years of age should be supervised in the use of the product
  • children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor
Description

Active Ingredient Benzocaine 20%

Section 42229-5

Other Information

  • store at room temperature.
  • Lot. No and Exp. Date: see crimp of tube.
Section 50565-1

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop using this product and ask a doctor

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Section 50567-7

When using this product

  • avoid contact with the eyes
  • do not exceed recommended dosage
Section 51727-6

Inactive Ingredients

Ammonium Glycyrrhizate, Polyethylene glycol, Saccharin sodium, Sorbic acid, Flavor

Section 51945-4

Section 55105-1

Purpose

Anesthetic

Section 55106-9

Active Ingredient

Benzocaine 20%


Structured Label Content

Indications and Usage (34067-9)

Uses

for the temporary relief of pain associated with:

  • toothache
  • canker sores
  • cold sores
  • fever blisters
  • minor dental procedures
Dosage and Administration (34068-7)

Directions

adults and children 2 years of age and older:

  • break seal on tube
  • apply to the affected area up to 4 times daily or as directed by a dentist or a doctor
  • children under 12 years of age should be supervised in the use of the product
  • children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor
Warnings and Precautions (34071-1)

Warnings

  • do not use for more than 7 days unless directed by a dentist or a doctor
  • if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
Section 42229-5 (42229-5)

Other Information

  • store at room temperature.
  • Lot. No and Exp. Date: see crimp of tube.
Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop using this product and ask a doctor

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes
  • do not exceed recommended dosage
Section 51727-6 (51727-6)

Inactive Ingredients

Ammonium Glycyrrhizate, Polyethylene glycol, Saccharin sodium, Sorbic acid, Flavor

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anesthetic

Section 55106-9 (55106-9)

Active Ingredient

Benzocaine 20%


Advanced Ingredient Data


Raw Label Data

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