Vistacaine topical anesthetic gel

Active ingredients (in each gram)

Benzocaine 200 mg

Purpose

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Warnings

  • Allergy Alert:Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
  • Do Not Usefor more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
  • When using this productavoid contact with eyes. If contact occurs, flush with water.
  • Stop use and consult a health care practitionerif the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
  • Do not exceed recommended dosage.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
  • If pregnant or breast feeding,ask a health professional before use.

Keep out of reach of children.

Keep Out of Reach of Children.

Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.

Other information

Store at 59 -86F (15 - 30C).

Protect from freezing.

Inactive ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #5, red #3, red #28, red #40, yellow #5 (tartrazine), as a color additive.

Questions or comments?

1-262-636-9755

Ingredients and appearance - Product information

Vistacaine topical anesthetic gel- Benzocaine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 64522-002
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Benzocaine ( UNII: U3RSY48JW5)( Benzocaine - UNII: U3RSY48JW5 ) 200 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Polyethylene glycol 3350 ( UNII: G2M7P15E5P)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Saccharin sodium ( UNII: SB8ZUX40TY)
Water ( UNII: 059QF0KO0R)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
D&c green no. 5 ( UNII: 8J6RDU8L9X)
Fd&c red no. 3 ( UNII: PN2ZH5LOQY)
D&c red no. 28 ( UNII: 767IP0Y5NH)
Fd&c yellow no. 5 ( UNII: I753WB2F1M)
Fd&c red no. 40 ( UNII: WZB9127XOA)

Product Characteristics

Color green Flavor MINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part356 USA

Labeler - Inter-Med, INC.( 036623932)

Package label.principal display panel