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Drug Facts
Oral Pain Relief Gel
FDA Label NDC 81417-121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sled Distribution, Llc for the product Oral Pain Relief Gel (NDC 81417-121). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, 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
Otc - Active Ingredient
Active ingredient
Benzocaine 20% (w/w)
Otc - Purpose
Purpose
Oral anesthetic
Indications & Usage
Uses
For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.
Warnings
Warnings
For oral use only.
Otc - Do Not Use
stop use and ask a doctor if get any discomfort.
Otc - Stop Use
Stop use and ask a dentist or doctor if
- sore mouth does not improve in 7 days
- irritation, pain, or redness persists or worsens
- swelling, rash, fever or other allergic reaction develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If accidentally swallowed get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Adults and children (2 years and older):
Dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.
Inactive Ingredient
Inactive ingredients
Polyethylene Glycol, Fragrance
Package Label.Principal Display Panel
Benzocaine 20% | Oral Anesthetic
NET WT 0.75 g
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