Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 194150a3-7492-4d7d-84e2-5b4297000eae
Route
TOPICAL
Published
Effective Date 2010-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Sorbic Acid Methylparaben Propylparaben Fd&c Yellow No. 5 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-02-01

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:

  • cut open tip of tube
  • apply to the affected area 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 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 box or 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 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 Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40

Section 51945-4
Package Label



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:

  • cut open tip of tube
  • apply to the affected area 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 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 box or 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 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 Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40

Section 51945-4 (51945-4)
Package Label



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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