Topical Anesthetic
FDA Label NDC 43128-021

16 label sections · Submitted to the FDA by Ndc, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ndc, Inc. for the product Topical Anesthetic (NDC 43128-021). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, 1. indications and usage, 2. dosage and administration, 3. dosage forms and strength, 4. contraindications, methemoglobinemia warning, 6. overdosage, 7. description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

For dental use only

Rx only

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

1. 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.

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

Storage And Handling

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

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)

Principal Display Panel (34g Jar Label)

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)

Principal Display Panel (34g Jar Label)

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)

Principal Display Panel (34g Jar Label)

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)

Principal Display Panel (34g Jar Label)

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)

Principal Display Panel (34g Jar Label)

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)

Principal Display Panel (34g Jar Label)

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