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

Description

Benzocaine 200mg

Purpose

Oral Anesthetic


Medication Information

Purpose

Oral Anesthetic

Description

Benzocaine 200mg

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

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.

Directions

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

Questions?

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

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.

Active Ingredients (in Each Gram)

Benzocaine 200mg


Structured Label Content

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)

Purpose

Oral Anesthetic

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.

Directions

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

Questions?

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

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.

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

Benzocaine 200mg


Advanced Ingredient Data


Raw Label Data

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