FDA.reportPublic FDA data

TANAC Oral Pain Reliever

Manufacturer
Leosons Overseas Corp
Effective date
2024-11-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:38:24

Label at a glance#

ProductTANAC Oral Pain Reliever
Active ingredientBENZOCAINE
Label structure8 sections

Indications and uses

Temporarily relieves pain due to canker sores cold sores fever blisters minor irritations or injury of the mouth and gums

Dosage and administration

apply product with cotton swab or clean fingertip to the affected area adults and children 2 years of age and older : use up times 4 times daily or as directed by a dentist or doctor. Children should be supervised in the use of this product. children under 2 years of age : do not use

Label contents#

Full prescribing information#

Active Ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Benzocaine 10%........................................................Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain due to

  • canker sores
  • cold sores
  • fever blisters
  • minor irritations or injury of the mouth and gums

Warnings

WARNINGS SECTION

For oral use only.

WARNINGS SECTION

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

WARNINGS SECTION

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as
procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use
and seek medical help right away.

WARNINGS SECTION

Flammability warning: Keep away from fire or flame.

Stop use and ask a doctor or dentist if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • sore mouth symptoms do not improve in 7 days
  • symptoms clear up and occur again within a few days
  • irritation, pain or redness persists or worsens swelling, rash, or fever develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Do not use

OTC - DO NOT USE SECTION

  • for teething
  • in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not use more than directed
  • do not use for more than 7 days unless directed by a dentist or doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply product with cotton swab or clean fingertip to the affected area
  • adults and children 2 years of age and older: use up times 4 times daily or as directed by a

dentist or doctor. Children should be supervised in the use of this product.

  • children under 2 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • store at 20 - 25°C (68 - 77°F)
  • do not use if imprinted safety seal is torn, broken or missing prior to opening
  • keep carton for full drug facts

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, peppermint oil, polyethylene glycol 400, propylene glycol, sodium saccharin, tannic acid

Questions?

OTC - QUESTIONS SECTION

1-855-452-9500 or email at info@leosonsintl.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • canker sores
  • gum irritations
  • cold sores
  • fever blisters

Tanac ®

Benzocaine 10%

Oral Pain Reliever

NO STING LIQUID

0.45 FL Oz. (13.3mL)

Tanac BoxTanac Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
583152benzocaine 10 % Mucous Membrane Topical SolutionPSN4
1053339Tanac Liquid 10 % Mucous Membrane Topical SolutionPSN4
1053339benzocaine 100 MG/ML Mucous Membrane Topical Solution [Tanac Liquid]SBD4
583152benzocaine 100 MG/ML Mucous Membrane Topical SolutionSCD4
583152benzocaine 10 % Mucous Membrane Topical SolutionSY4
1053339Tanac Liquid 10 % Mucous Membrane Topical SolutionSY4
1053339Tanac Liquid 100 MG/ML Mucous Membrane Topical SolutionSY4

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
69626-0049-42024-11-20C16284748780-10191ceaa-6169-198a-e063-dbdaa90aec3eTANAC Oral Pain Reliever
69626-0049-42023-07-28C16284748780-10191ceaa-6169-198a-e063-dbdaa90aec3eTANAC Oral Pain Reliever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0049-4TANAC Oral Pain Reliever13.3 mL in 1 BOTTLELIQUID13.34
69626-0049-4TANAC Oral Pain Reliever1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0049TANAC ORAL PAIN RELIEVER (BENZOCAINE) LIQUID [LEOSONS OVERSEAS CORP]4Current NDC, Legacy NDC, 2 package rows20241122_81cc61fa-31a7-2214-e053-2a91aa0ae46a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69626-004969626-0049-4

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
TANNIC ACID28F9E0DJY6IACT
PEPPERMINT OILAV092KU4JHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
BENZOCAINEU3RSY48JW5ACTIB

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
TANAC Oral Pain RelieverBENZOCAINELeosons Overseas Corp81cc61fa-31a7-2214-e053-2a91aa0ae46a2024-11-15WarningsExact identifier
ndc (package): 69626-0049-4
ndc (product): 69626-0049
ndc11 (package): 69626004904
spl id: 26f71ff3-08b2-6177-e063-6394a90ace74
spl set id: 81cc61fa-31a7-2214-e053-2a91aa0ae46a

Reported adverse events (FAERS/openFDA)#

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