Prime-Gel BENZOCAINE PRIME DENTAL MANUFACTURING, INC. FDA Approved 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.

PRIME-GEL

Generic: BENZOCAINE
Mfr: PRIME DENTAL MANUFACTURING, INC. FDA OTC
FunFoxMeds box
Substance Benzocaine
Route
DENTAL ORAL PERIODONTAL
Applications
M022
Product NDC
77794-0018-00 77794-0018-17
Package NDC
77794-018-17 77794-018-00

Drug Facts

Composition & Profile

Active Ingredients
Active Ingridient: Benzocaine 0.2 g (200mg) per gram. See drug facts.
Inactive Ingredients
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.
Strengths
0.2 g 200 mg
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
NDC 77794-0018-00
All Product Codes
77794-0018-00 77794-0018-17
UNII
U3RSY48JW5
SPL Set IDs
ab6ef479-2567-0cf2-e053-2a95a90a272a
Packaging

Package Labelling NDC 77794-018-017

Package Descriptions
  • Package Labelling NDC 77794-018-017
Overview

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.

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.

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.

Warnings & 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.
Purpose

Purpose: Oral Anesthetic. See drug facts.

Keep Out of Reach of Children

Keep out of reach section. See drug facts:

Questions

Contact 773-283-2914

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Additional Information

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