Oral Analgesic
FDA Label NDC 51852-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lifelabs, A Division Of Atico International Usa, Inc. for the product Oral Analgesic (NDC 51852-101). 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 oral analgesic (maximum strength), otc - purpose, warnings, indications & usage, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Oral Analgesic (Maximum Strength)

Active Ingredient

Benzocaine 20%

Otc - Purpose

Purpose

Oral pain reliever


Uses

temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters,  minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

Warnings

for temporary use only until a dentist can be consulted



Allergy alert:

do not use this product if you have a history of allergy to local anesthetics such a procaine, butacaine, benzocaine or other "caine" anesthetics.

Indications & Usage

When using this product

  • do not use more than directed
  • do not use for more than 7 days unless directed by a doctor/dentist
  • do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist

Otc - Stop Use

Stop use and ask a doctor if

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In cases of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • remove cap and cut tip of tube on score mark
  • adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. use up to 4 times daily or as directed by a doctor or dentist.
  • children under 12 year of age: should be supervised in the use of this product
  • children under 2 years of age: ask a doctor/dentist

Storage And Handling

Other information

  • store at 15o to 25o (50o to 77oF)
  • This preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted. Do not use continuously
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive Ingredients

d-sorbitol solution, glycerin, peppermint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium

Otc - Questions

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

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