Benzo-jel topical anesthetic gel

Active ingredients (in each gram)

Benzocaine 200mg

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 healthcare 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 accidentallyswallowed, get medical help or contact aPoison Control Center immediately.
  • If pregnant or breast feeding,ask a health professional before use.

Dosage & administration section

Do not exceed recommended dosage.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Otc - keep out of reach of children section

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 saccharine. May contain yellow #5 (tartrazine), yellow #6, red #3, red #40, blue #1, green #3 as a color additive.

Ingredients and appearance - Product information

Benzo-jel topical anesthetic gel- Benzocaine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0404-0024
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)

Product Characteristics

Flavor MINT Color green

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0404-0024-30 30g in 1 JAR 2016/05/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part356 USA 2016/05/01

Labeler - Henry Schein Inc.( 012430880)

Package label.principal display panel