Active Ingredient
Benzocaine 20.0% (w/w)...................................................................... Oral anesthetic
Topcare Liquid
FDA Label NDC 36800-443
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare (NDC 36800-443). 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, uses, 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
Uses
Temporarily relieves pain associated with the following mouth and gum irritations: •toothache •sore gums •canker sores •braces •minor dental procedures
Warnings
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
When using this product •avoid contact with eyes •do not exceed recommended dosage •do not use for more than 7 days unless directed by a dentist or doctor
Stop use and ask doctor or dentist if •sore mouth symptoms do not improve in 7 days •irritation, pain or redness persists or worsens •swelling, rash or fever develops
Otc - 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.
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: consult a dentist or doctor
Other Information
do not use if package has been opened
store at 20 - 25 C (68-77F)
close cap tightly after use to avoid evaporation
avoid contact with eyes
avoid contact with clothing and household furniture surfaces to avoid possible staining
this is a personal care item, and should be used by one individual only
Inactive Ingredients
Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water
Package Label.Principal Display Panel
Bottle
Blister
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