FDA.reportPublic FDA data

BLT 3

Manufacturer
CENTURA PHARMACEUTICALS INC
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:32:31

Label at a glance#

ProductBLT 3
Active ingredientTETRACAINE
Label structure8 sections

Indications and uses

For the temporary relief of pain and itching.

Dosage and administration

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Storage and handling

Store below 77° F (25° C). Avoid direct sunlight.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Tetracaine 2%

PURPOSE

OTC - PURPOSE SECTION

Topical Anesthetic

USES

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching.

WARNINGS

WARNINGS SECTION

• For external use only.
• Avoid contact with eyes or mucus membranes.
• Do not apply to open or damaged skin.
• If condition worsens or symptoms persist for
more than seven days, discontinue use and
consult physician.
• If pregnant or breast feeding,contact physician
prior to use.
• Keep out of reach of children. If swallowed,
contact Poison Control Center.
• Do not use if allergic to any ingredient in ointment.
• Do not use in large quantities, particularly over
raw surfaces or blistered areas.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children two-years of age or
older: Apply to affected area not more than three to
four times daily. Children under two-years of age:
consult a physician.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store below 77° F (25° C). Avoid
direct sunlight.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), PEG-8 Stearate, PEG-100 Stearate, PEG8, PEG-75,Methylisothiazolinone

PACKAGE LABELING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLT3BLT3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1858385tetracaine 2 % Topical OintmentPSN8
1858385tetracaine 0.02 MG/MG Topical OintmentSCD8
1858385tetracaine 2 % Topical OintmentSY8

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130647356934780GTIN-13: 0647356934780
EAN-13: 0647356934780
GTIN-12: 647356934780
UPC-A: 647356934780
GTIN storage (14 digits): 00647356934780		BLT3 NEW IMAGE 1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70372-729-01BLT 35 g in 1 POUCHOINTMENT58

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70372-72970372-729-01

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
TETRACAINE0619F35CGVACTIB
WATER059QF0KO0RIACT
PEG-100 STEARATEYD01N1999RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PEG-8 STEARATE2P9L47VI5EIACT

Source Document#

Source XML · Source PDF

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
BLT 3TETRACAINECENTURA PHARMACEUTICALS INC401a0d22-1181-02ac-e054-00144ff88e882026-01-12WarningsExact identifier
ndc (package): 70372-729-01
ndc (product): 70372-729
ndc11 (package): 70372072901
spl id: 4839627e-93c0-0a1a-e063-6394a90a05b5
spl set id: 401a0d22-1181-02ac-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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