Benzo-jel topical anesthetic gel
Active ingredients (in each gram)
For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
- 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.
Apply only amount needed to the oral mucosa to prevent or relieve pain.
Store at 59-86F (15-30C). Protect from freezing.
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 Type||HUMAN OTC DRUG LABEL||Item Code (Source)||NDC: 0404-0024|
|Route of Administration||Dental|
|Benzocaine ( UNII: U3RSY48JW5)( Benzocaine - UNII: U3RSY48JW5 )||200 mgin 1 g|
|Polyethylene glycol 3350||( UNII: G2M7P15E5P)|
|Polyethylene glycol 400||( UNII: B697894SGQ)|
|Saccharin sodium||( UNII: SB8ZUX40TY)|
|#||Item Code||Package Description||Marketing Start Date|
|1||NDC: 0404-0024-30||30g in 1 JAR||2016/05/01|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
|OTC monograph not final||part356||USA||2016/05/01|