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Topical Anesthetic Dental Gel Prescribing Information

Package insert / product label
Generic name: benzocaine
Dosage form: gel
Drug class: Topical anesthetics

Medically reviewed by Drugs.com. Last updated on Sep 14, 2023.

Gel – 1oz/34g
2731001 Cherry
2731002 Mint
2731004 Pina Colada
2731005 Bubble Gum
2731006 Strawberry
2731007 Raspberry

For dental use only

Rx only

1. Indications and Usage for Topical Anesthetic Dental Gel

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs.

2. Topical Anesthetic Dental Gel Dosage and Administration

❖
Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle.
❖
Tightly re-cap the jar after each use.

3. Dosage Forms and Strengths

Each gram of 20% Benzocaine Gel contains between 180-220 mg benzocaine in a flavored base.

4. Contraindications

Should not be used with individuals with a known sensitivity to benzocaine or PABA.

5. Warnings and Precautions

METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient in your care develops:

•
pale, gray or blue colored skin (cyanosis)
•
headache
•
rapid heart rate
•
shortness of breath
•
dizziness or lightheadedness
•
fatigue or lack of energy
❖
Not for use in children under 2 years of age
❖
Keep out of reach of children
❖
For professional dental use only
❖
Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle

6. Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away.

7. Topical Anesthetic Dental Gel Description

Flavored 20% benzocaine gel for topical mucosa anesthesia

8. How is Topical Anesthetic Dental Gel supplied

20% benzocaine gel is supplied in multiple use containers

Store between 59°-86°F (15°-30°C). Protect from freezing.

For more information call NDC at 1-800-929-4232
Manufactured for NDC Nashville, TN 37217
Made in the USA
2731001DF, R1-120116

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry

Topical Anesthetic Gel
20% Benzocaine
Cherry

REF: 2731001

CHERRY

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-021-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Cherry

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint

Topical Anesthetic Gel
20% Benzocaine
Mint

REF: 2731002

MINT

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-023-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Mint

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada

Topical Anesthetic Gel
20% Benzocaine
Piña Colada

REF: 2731004

PIÑA COLADA

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-024-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Piña Colada

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum

Topical Anesthetic Gel
20% Benzocaine
Bubble Gum

REF: 2731005

BUBBLE GUM

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-022-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Bubble Gum

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry

Topical Anesthetic Gel
20% Benzocaine
Strawberry

REF: 2731006

STRAWBERRY

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-020-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Strawberry

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry

Topical Anesthetic Gel
20% Benzocaine
Raspberry

REF: 2731007

RASPBERRY

Quala®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only
NDC 43128-026-30

PRINCIPAL DISPLAY PANEL - 34g Jar Label - Raspberry
TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-021
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Saccharin Sodium (UNII: SB8ZUX40TY)
Water (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
ColorREDScore
ShapeSize
FlavorCHERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43128-021-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-023
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Saccharin Sodium (UNII: SB8ZUX40TY)
Water (UNII: 059QF0KO0R)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
Product Characteristics
ColorGREENScore
ShapeSize
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43128-023-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-024
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Saccharin Sodium (UNII: SB8ZUX40TY)
Water (UNII: 059QF0KO0R)
Product Characteristics
ColorWHITEScore
ShapeSize
FlavorCOCONUT (Pina Colada) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43128-024-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-022
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Saccharin Sodium (UNII: SB8ZUX40TY)
Water (UNII: 059QF0KO0R)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
Product Characteristics
ColorPINKScore
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43128-022-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-020
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Saccharin Sodium (UNII: SB8ZUX40TY)
Water (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
ColorREDScore
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43128-020-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43128-026
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Saccharin Sodium (UNII: SB8ZUX40TY)
Water (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
ColorREDScore
ShapeSize
FlavorRASPBERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43128-026-3034 g in 1 JAR; Type 0: Not a Combination Product02/19/1963
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
Labeler - NDC, Inc. (009831413)
Establishment
NameAddressID/FEIBusiness Operations
Caulk083235549MANUFACTURE(43128-021, 43128-023, 43128-024, 43128-022, 43128-020, 43128-026)

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