Otc - Active Ingredient
Active ingredient Purpose
Benzocaine 20%............................................Oral Pain Reliever
Iodent Oral Analgesic Gel
FDA Label NDC 65923-094
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Iodent Oral Analgesic (NDC 65923-094). 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 - stop use, 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 - Purpose
Uses
for the temporary relief of pain due to toothaches
Warnings
Warnings
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
- more than directed
- for more than 7 days unless today to do so by a dentist or doctor
Otc - Stop Use
Stop use and ask a doctor if
- swelling, rash or fever develops
- irritations, pain or redness persists or worsens
- symptoms do not get better 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 immediately
Indications & Usage
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 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°)
- do not use if tube tip 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
glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol
Dosage & Administration
Distributed by:
United Exchange Corp.
5836 Corporate Ave.
Cypress, CA 90630 USA
1-800-814-8028
Made in China
* Please review the disclaimer below.
