Oral Pain Relief Gel
FDA Label NDC 73492-717

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alaina Healthcare Private Limited for the product Oral Pain Relief (NDC 73492-717). 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, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

Active ingredients                                                                        Purpose

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

Indications & Usage

Uses

  • temporarily relieves pain associated with the following mouth and gum irritations:
  • toothache
  • canker sores
  • minor dental procedures
  • dentures
  • sore gums
  • braces

Warnings

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 you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

    Do not use:

    • for teething
    • in children under 2 years of age

Otc - Ask Doctor

When using this product:

  • avoid contact with the eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a doctor/dentist

    • Stop use and ask doctor if

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions:

adults and children 2 years of age and over

apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist

children under 12 years of age

adult supervision should be given in the use of this product

children under 2 years of age

do not use

  • For denture irritation:
  • apply thin layer to the affected area
  • do not reinsert dental work until irritation/pain is relieved
  • rinse mouth well before reinserting

    • Other information

    • store at 20-25°C (68-77°F)
    • do not refrigerate

Inactive Ingredient

Inactive Ingredients

benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid

Package Label.Principal Display Panel

MAXIMUM STRENGTH

ORAL PAIN RELIEF GEL

FAST ACTING

Benzocaine 20% pain relieving gel

NET WT 0.5 OZ (14g)

Label (Oral Pain Relief Tube)

Label (Oral Pain Relief Tube)

Label (Oral Pain Relief Carton)

Label (Oral Pain Relief Carton)

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