ab6ef479-2567-0cf2-e053-2a95a90a272a
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Use for Oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures. Do not use for more than 7 days unless directed by a dentist or doctor. See drug facts.
Medication Information
Warnings and Precautions
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 occures, 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 swaloowed, get medical help or contact a posion control center immediately.
If pregnant or breast feeding, ask a health care proffesional before use.
Keep out of reach of children.
Indications and Usage
Use: for Oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Indications/Directions: Apply only amount needed to the oral mucosa to prevent or relieve pain.
See drug facts.
Dosage and Administration
Use for Oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Do not use for more than 7 days unless directed by a dentist or doctor.
See drug facts.
Description
Use for Oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures. Do not use for more than 7 days unless directed by a dentist or doctor. See drug facts.
Section 43685-7
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 occures, 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 swaloowed, get medical help or contact a posion control center immediately.
If pregnant or breast feeding, ask a health care proffesional before use.
Keep out of reach of children.
Section 50565-1
Keep out of reach section.
See drug facts:
Section 50568-5
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.
Section 53413-1
Contact 773-283-2914
Section 53414-9
If pregnant or breast feeding ask a health care professional before use.
Section 55105-1
Purpose: Oral Anesthetic.
See drug facts.
Section 55106-9
Active Ingridient: Benzocaine 0.2 g (200mg) per gram.
See drug facts.
Package Labelling
List of Inactive Ingredients
Flavoring, PEG3350, PEG400, sodium saccharin, water. may contain blue#, green #5, red #3, red #28, red#40, yellow #5 as color additives.
Structured Label Content
Indications and Usage (34067-9)
Use: for Oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Indications/Directions: Apply only amount needed to the oral mucosa to prevent or relieve pain.
See drug facts.
Dosage and Administration (34068-7)
Use for Oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Do not use for more than 7 days unless directed by a dentist or doctor.
See drug facts.
Warnings and Precautions (34071-1)
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 occures, 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 swaloowed, get medical help or contact a posion control center immediately.
If pregnant or breast feeding, ask a health care proffesional before use.
Keep out of reach of children.
Section 43685-7 (43685-7)
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 occures, 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 swaloowed, get medical help or contact a posion control center immediately.
If pregnant or breast feeding, ask a health care proffesional before use.
Keep out of reach of children.
Section 50565-1 (50565-1)
Keep out of reach section.
See drug facts:
Section 50568-5 (50568-5)
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.
Section 53413-1 (53413-1)
Contact 773-283-2914
Section 53414-9 (53414-9)
If pregnant or breast feeding ask a health care professional before use.
Section 55105-1 (55105-1)
Purpose: Oral Anesthetic.
See drug facts.
Section 55106-9 (55106-9)
Active Ingridient: Benzocaine 0.2 g (200mg) per gram.
See drug facts.
Package Labelling
List of Inactive Ingredients
Flavoring, PEG3350, PEG400, sodium saccharin, water. may contain blue#, green #5, red #3, red #28, red#40, yellow #5 as color additives.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T11:59:32.346360 · Updated: 2026-03-14T23:13:06.603726