FDA Label for Topcare Maximum Strength

Active Ingredient

Benzocaine 20.0% (w/w)...................................................................... Oral anesthetic

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