Oral Pain Relief Gel
FDA Label NDC 57896-139

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Oral Pain Relief (NDC 57896-139). 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 other, active ingredient, purpose, uses, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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. If a skin reaction occurs, stop use and seek medical help right away.

Active Ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Uses

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

Do Not Use

• for teething

• in children under 2 years of age

• more than recommended
• for more than 7 days unless told to do so by a dentist or doctor

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

Directions

• do not exceed recommended dosage

• do not use for more than 7 days unless told to do so by a dentist or doctor

• adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist
• children between 2 and 12 years of age: adult supervision should be given in use of this product
• children under 2 years of age: do not use

Other Information

• do not use tube if it is cut prior to opening

• to open tube, cut open tip of tube on score mark with scissors
• store at a controlled room temperature 68°-77°F (20°-25°C)

Inactive Ingredients

Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic Acid

Questions Or Comments?

1-800-540-3765

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