Dosage & 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.
Prime-gel
FDA Label NDC 77794-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Dental Manufacturing, Inc. for the product Prime-gel (NDC 77794-018). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage & administration, list of inactive ingredients, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, warnings and precautions, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Indications & 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach section.
See drug facts:
Otc - Purpose
Purpose: Oral Anesthetic.
See drug facts.
Otc - Active Ingredient
Active Ingridient: Benzocaine 0.2 g (200mg) per gram.
See drug facts.
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.
Otc - Questions
Contact 773-283-2914
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding ask a health care professional before use.
Otc - Ask Doctor/Pharmacist
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.
Warnings
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.
Package Labelling
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