ipana 20% benzocaine topical peppermint

ipana 20% benzocaine topical peppermint
SPL v9
SPL
SPL Set ID c13761e0-d45d-4e0f-ac41-428e005f96bb
Route
dental
Published
Effective Date 2016-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (200 mg)
Inactive Ingredients
polyethylene glycol 400 saccharin sodium fd&c yellow no. 5 fd&c yellow no. 6 fd&c red no. 3 fd&c red no. 40 fd&c blue no. 1 fd&c green no. 3 polyethylene glycol 3350

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2016-08-01

Purpose

Oral Anesthetic

Description

Benzocaine 200mg


Medication Information

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 use ​for 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 product ​avoid contact with eyes. If contact occurs, flush with water.

​Stop use and consult a health care practitioner ​if 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 breastfeeding, ​ask a health professional before use.

Purpose

Oral Anesthetic

Directions

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

Other Information

Store at 59°-86°F (15°-30°C). Protect from freezing.

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain yellow #5 (tartrazine), yellow #6, red #3, red #40, blue #1, green #3 as a color additive.

Description

Benzocaine 200mg

Questions?

1-855-462-9455 or 1-519-631-7370

Use

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

Section 50565-1

​Keep out of reach of children.

Section 51945-4

Active Ingredients (in Each Gram)

Benzocaine 200mg


Structured Label Content

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 use ​for 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 product ​avoid contact with eyes. If contact occurs, flush with water.

​Stop use and consult a health care practitioner ​if 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 breastfeeding, ​ask a health professional before use.

Purpose

Oral Anesthetic

Directions

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

Other Information

Store at 59°-86°F (15°-30°C). Protect from freezing.

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain yellow #5 (tartrazine), yellow #6, red #3, red #40, blue #1, green #3 as a color additive.

Questions?

1-855-462-9455 or 1-519-631-7370

Use

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

Section 50565-1 (50565-1)

​Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredients (in Each Gram) (Active Ingredients (in each gram))

Benzocaine 200mg


Advanced Ingredient Data


Raw Label Data

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