Topical Anesthetic

TOPICAL ANESTHETIC- benzocaine gel
NDC, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

For dental use only

Rx only

1. Topical Anesthetic Indications and Usage

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. 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 STRENGTH

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. DESCRIPTION

Flavored 20% benzocaine gel for topical mucosa anesthesia

8. HOW SUPPLIED/STORAGE AND HANDLING

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 — 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 — 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 — 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 — 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 — Raspberry

Topical Anesthetic Gel
20% Benzocaine
Raspberry

REF: 2731007

RASPBERRY

Quala_®
DENTAL PRODUCTS

NET CONTENTS:
1 oz (34g)

Rx Only NDC 43128-026-30

TOPICAL ANESTHETIC benzocaine gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-021 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg in 1 g

Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water FD&C RED NO. 40

Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43128-021-30 34 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963

TOPICAL ANESTHETIC benzocaine gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-023 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg in 1 g

Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water D&C GREEN NO. 5

Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43128-023-30 34 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963

TOPICAL ANESTHETIC benzocaine gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-024 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg in 1 g

Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water

Product Characteristics Color WHITE Score Shape Size Flavor COCONUT (Pina Colada) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43128-024-30 34 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963

TOPICAL ANESTHETIC benzocaine gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-022 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg in 1 g

Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water D&C RED NO. 28

Product Characteristics Color PINK Score Shape Size Flavor BUBBLE GUM Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43128-022-30 34 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963

TOPICAL ANESTHETIC benzocaine gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-020 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg in 1 g

Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water FD&C RED NO. 40

Product Characteristics Color RED Score Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43128-020-30 34 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963

TOPICAL ANESTHETIC benzocaine gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-026 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (Benzocaine) Benzocaine 220 mg in 1 g

Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Water FD&C RED NO. 40

Product Characteristics Color RED Score Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43128-026-30 34 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/19/1963

Labeler — NDC, Inc. (009831413)

Establishment
Name	Address	ID/FEI	Operations
Caulk		083235549	MANUFACTURE (43128-021), MANUFACTURE (43128-023), MANUFACTURE (43128-024), MANUFACTURE (43128-022), MANUFACTURE (43128-020), MANUFACTURE (43128-026)

Revised: 09/2018 NDC, Inc.