Active Ingredient
Benzocaine 20.0% (W/W)...................................................................... Oral anesthetic
Family Dollar
FDA Label NDC 55319-388
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc. for the product Family Dollar (NDC 55319-388). 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, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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
Use
Temporarily relieves pain associated with the following mouth and gum irritations:
*toothache * sore gums * canker sores * braces * minor dental procedures
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
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 • more than directed • for more than 7 days unless told to do so by a dentist or
doctor • for teething • in children under 2 years of age
Stop use and ask a doctor if • swelling, rash or fever develops • irritation, pain or redness
persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs
Keep out of reach of children. In case of overdose, get medical help or contact a Poison
Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control
Center right away.
Directions
Adults and children 2 years of age and older: • apply to affected area using
applicator tip • use up to 4 times daily or as directed by a dentist or doctor • 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
store at 20 - 25 C (68-77F)
Inactive Ingredients
Ethyl Alcohol 44.2 % by weight, Red 40, Yellow 5, Flavor, Polyethylene Glycol, Water, Sodium Saccharin
Package Label.Principal Display Panel
* Please review the disclaimer below.
