FDA Label for Oral Pain Relief Gel
View Indications, Usage & Precautions
Oral Pain Relief Gel Product Label
The following document was submitted to the FDA by the labeler of this product Sled Distribution, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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
* Please review the disclaimer below.