Winco Foods Maximum Strength Oral Analgesic Gel
FDA Label NDC 67091-198

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Foods Maximum Strength Oral Analgesic (NDC 67091-198). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                            Purpose

Benzocaine 20%........................................................... Oral pain reliever

Otc - Purpose

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

Allery 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

Otc - Do Not Use

Do not use

  • more than directed
  • for more than 7 days unless directed by a doctor/dentist

Otc - Ask Doctor

Stop use and ask a doctor if

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Indications & Usage

Directions

  • remove cap and cut tip of tube on score mark
  • adults an 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 years 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 15° to 25°C (59° to 77°F)
  • do not use if tube is cut prior to opening
  • 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. & exp. date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

flavor mint, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

Dosage & Administration

DISTRIBUTED BY:

WINCO FOODS, LLC

BOISE, ID 83704

MADE IN KOREA

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