Active Ingredients
Benzocaine 20%
Benzalkonium Chloride 0.1%
Oral Pain Relief
FDA Label NDC 47046-156
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anicare Pharmaceuticals Pvt. Ltd for the product Oral Pain Relief (NDC 47046-156). 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 ingredients, purpose, use, warnings, do not use, stop use and ask a physician if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral pain reliever
Antiseptic
Use
■ for the temporary relief of pain due to toothaches
■ to help protect against infection in minor oral irritation
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduce 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 lightheadness
• 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 or other "caine" anesthetics
Do Not Use
■ more than directed
■ for more than 7 days unless directed by a physician or healthcare provider
Stop Use And Ask A Physician If
■ swelling, rash or fever develops
■ irritation, pain or redness persists or worsens
■ symptoms do not improve in 7 days
Keep Out Of Reach Of Children
In case of overdose or allergic reaction get medical help or contact a Poison Control Center right away.
Directions
■ adults and children 2 years of age and over: apply a small amount of the product to the cavity and around the gum surrounding the teeth Use up to 4 times daily or as directed by a physician or healthcare provider
■ children under 12 years of age: should be supervised in the use of this product
■ children under 2 years of age: Do not use
Other Information
■ this preparation is intended for use in cases ot toothache, only as a temporary expedient until a physican can be consulted
■ do not use continuously
■ avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening
Inactive Ingredients
ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid, purified water, FD&C Yellow#5, FD&C Red#40
Package Label
Oral Pain Relief Gel
NET WT. 0.5 oz (14 g)
Image Description (Oral Gel)
* Please review the disclaimer below.
