Oral Pain Relief Gel
FDA Label NDC 43473-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nantong Health & Beyond Hygienic Products Inc. for the product Oral Pain Relief (NDC 43473-100). 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 drug facts, active ingredients, purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzocaine 20%
Purposes
Oral pain reliever
Uses
• 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 reduces 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 lightheadedness • fatigue or lack of energy
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. in case of overdose or allergic reaction, get medical help
Directions
• Adults and children 2 years of age and over: Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider • Children between 2 and 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 of toothache, only as a temporary expedient until a physician can be consulted • do not use continuosly • 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, Fragrance, Polyethylene Glycol 400, Polyethylene Glycol 4000, Saccharin Sodium, Sorbic Acid, Water
Packaging
Oral Pain Relief (52000443 3)
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