Iolite-s Spray
FDA Label NDC 53045-127

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dharma Research, Inc. for the product Iolite-s (NDC 53045-127). 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 active ingredient, purpose, uses, warnings, methemoglobinemia warning, allergy alert, otc - do not use, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Uses

For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.

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 the blood. This can occur even if you have use 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.

Otc - Do Not Use

Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persist or worsens, or if swelling, rash, or fever develops, see your dentist or doctor promptly.

  • For teething
  • In children under 2 years of age

    • Do not use near fire or flame. Flammable.

Other

Do not exceed recommended dosage.

Avoid spraying in the eyes.

Manufactured by:

Dharma Research, Inc.

www.dharmaresearch.com

5220 N.W. 72 Avenue, Unit 15

Miami, FL 33166

1-877-833-3725

NDC 53045-127-60

Iolite-S

Oral Anesthetic Spray

Gluten Free

Made in USA

2 fl. oz. (60 mL)

Fresh Spearmint

Otc - Keep Out Of Reach Of Children

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

Directions

Shake well before use. Firmly insert extension tube into spray can valve and ensure it fits securely in the actuator opening. Position the extension tube 1-2 inches from the affected area. Press 1/2 second (press and immediately release the actuator).

  • Adults and children 12 years of age and older: Apply to the affected area. Use 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 this product.
  • Children under 2 years of age: do not use.

Inactive Ingredients

Ethyl alcohol, Flavor, Isobutane (propellant), Polyethylene glycol, Propane (propellant), Saccharine sodium.

Other Information

Store at room temperature 59-86°F (15-30°C).

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