PRIME-GEL- benzocaine gel 
Prime Dental Manufacturing, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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.

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.

Keep out of reach section.

See drug facts:

Purpose: Oral Anesthetic.

See drug facts.

Active Ingridient: Benzocaine 0.2 g (200mg) per gram.

See drug facts.

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.

Contact 773-283-2914

If pregnant or breast feeding ask a health care professional before use.

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

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

NDC 77794-018-017

PRIME-GEL 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77794-018
Route of AdministrationPERIODONTAL, DENTAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 0.69 g  in 1 g
HC RED NO. 3 (UNII: 51CPX7M1SQ) 0.0006 g  in 1 g
SACCHARIN (UNII: FST467XS7D) 0.045 g  in 1 g
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 0.05 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77794-018-0024 in 1 BOX, UNIT-DOSE12/15/2020
1NDC:77794-018-1729.6 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/15/2020
Labeler - Prime Dental Manufacturing, Inc. (083614037)
Establishment
NameAddressID/FEIBusiness Operations
Prime Dental Manufacturing, Inc.083614037manufacture(77794-018)

Revised: 4/2021
Document Id: c133c7ce-0a1b-5d8b-e053-2a95a90a5dc6
Set id: ab6ef479-2567-0cf2-e053-2a95a90a272a
Version: 2
Effective Time: 20210430
 
Prime Dental Manufacturing, Inc.