PRIME-GEL- benzocaine gel

Prime-Gel by

Drug Labeling and Warnings

Prime-Gel by is a Otc medication manufactured, distributed, or labeled by Prime Dental Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach section.

See drug facts:

PURPOSE

Purpose: Oral Anesthetic.

See drug facts.

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.

QUESTIONS

Contact 773-283-2914

PREGNANCY OR BREAST FEEDING

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

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

INGREDIENTS AND APPEARANCE

PRIME-GEL 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77794-018
Route of Administration	PERIODONTAL, DENTAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77794-018-00	24 in 1 BOX, UNIT-DOSE	12/15/2020
1	NDC: 77794-018-17	29.6 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/15/2020

Labeler - Prime Dental Manufacturing, Inc. (083614037)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Dental Manufacturing, Inc.		083614037	manufacture(77794-018)