Active Ingredient
Benzocaine 20.0% (w/w)
Oral Anesthetic Liquid
FDA Label NDC 79481-0118
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Oral Anesthetic Liquid (NDC 79481-0118). 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 ingredient, purpose, uses, warnings, directions, inactive ingredients, keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral pain reliever
Uses
Temporarily relieves pain associated with the following mouth and gum irritations:
- toothache
- sore gums
- canker sores
- braces
- minor dental procedures
- dentures
Warnings
METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious confition 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
- for teething
- in children under 2 years of age
- avoid contact with eyes
- do not exceed recommended dosage
- do not use for more than 7 days unless directed by a dentist or doctor
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
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
Do not use
When using this product
Stop use and ask doctor if
Directions
Adults and children 2 years of age and older: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist
- children under 12 years of age: adult supervision should be given in the use of this product
- children under 2 years of age: do not use
- for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
Inactive Ingredients
Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
Card R1 (Meijer Oralpain Liquid Card 2824626r1)
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