Quality Choice Maximum Strength Oral Pain Relieving

Manufacturer
Chain Drug Marketing Association Inc
Effective date
2019-08-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:02

Label at a glance#

ProductQuality Choice Maximum Strength Oral Pain Relieving
Active ingredientBENZOCAINE
Label structure12 sections

Storage and handling

Other information store at room temperature 20° to 25°C (68° to 77°F) this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted do not use continuously

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Benzocaine 20%..........................................................................Oral pain reliever

OTC - PURPOSE SECTION

Uses

  • for the temporarily relieves pain due to:
  • toothache
  • canker sores
  • gum pain
  • denture pain
  • cheek bites

WARNINGS SECTION

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child 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

Allergy alert: do not use this product if your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

OTC - DO NOT USE SECTION

Do not use

  • more than directed
  • for more than 7 days unless directed by a doctor
  • for teething
  • in children under 2 years of age

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In cases of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Directions

Adults and children 2 years of age and older.

Remove cap and cut tip of tube. Apply a small amount of

product to the cavity and around gum surrounding the teeth.

Use up to 4 times daily or as directed by a dentist or doctor.

Children under 12 years of age.Should be supervised in the use of this product.
Children under 2 years of age.Do not use.

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20° to 25°C (68° to 77°F)
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted
  • do not use continuously

INACTIVE INGREDIENT SECTION

Inactive ingredients

glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

DOSAGE & ADMINISTRATION SECTION

Distributed By C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

phph

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN1
238910benzocaine 0.2 MG/MG Oral GelSCD1
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-477-112022-01-28C16284748780-1d6a99b39-b92b-a426-e053-dadaa90af4c2QC Maximum Strength Oral Analgesic 0.42oz 95362 (2019) - ZDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-477-11Quality Choice Maximum Strength Oral Pain Relieving11.9 g in 1 TUBEGEL11.91
63868-477-11Quality Choice Maximum Strength Oral Pain Relieving1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-477QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING (BENZOCAINE) GEL [CHAIN DRUG MARKETING ASSOCIATION INC]1Legacy NDC, 2 package rows20190810_8fb7d70c-3d6c-41a6-e053-2995a90a5138.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-47763868-477-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8fb7f300-a2c0-efa1-e053-2a95a90a87238fb7d70c-3d6c-41a6-e053-2995a90a51382019-08-09WarningsExact identifier
spl id: 8fb7f300-a2c0-efa1-e053-2a95a90a8723
spl set id: 8fb7d70c-3d6c-41a6-e053-2995a90a5138

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.