FDA.reportPublic FDA data

burn solution cream

Manufacturer
Burn Solution Foundations | Bio-Medical & Pharmaceutical Manufacturing Corporation
Effective date
2021-04-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:59

Label at a glance#

Productburn solution cream
Active ingredientTETRACAINE
Label structure10 sections

Dosage and administration

• Apply this product topically to affected areas. • Use up to 3 times daily. • Use only as directed.

Label contents#

Full prescribing information#

Drug Facts

STATEMENT OF IDENTITY SECTION

Topical Burn Cream plus Pain Relief

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetracaine (1.0%).......................Pain & Itch Relief

Purpose

OTC - PURPOSE SECTION

For temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, sprains, and burns

Indications

INDICATIONS & USAGE SECTION

• For cooling, deep-penetrating pain relief, apply a thin layer sparingly to affected areas.
• Apply up to 3 times daily

Warnings

WARNINGS SECTION

• Not for use on children under 2 years old except as directed by a doctor.
• Avoid contact with the eyes.
• For external use only.
• If irritation develops and persists, discontinue use and consult a doctor.
• If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply this product topically to affected areas.
• Use up to 3 times daily.
• Use only as directed.

Other Information

OTHER SAFETY INFORMATION

External Anesthetic

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Stearic Acid, Lauramide DEA, Beeswax, Propylene Glycol, Sodium Tetraborate, Sodium Lauryl Sulfate, Diazolidinyl Urea,
Methylparaben, Propylparaben, Triethanolamine, Eucalyptus Oil.

Questions or Comments

OTC - QUESTIONS SECTION

Burn Solution Foundation
Land O Lakes, FL
888.368.0555
relief-roller.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

starell starellstarell

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313246tetracaine HCl 1 % Topical CreamPSN3
313246tetracaine 10 MG/ML Topical CreamSCD3
313246tetracaine 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70704-212-202024-01-30C16284748780-11030e365-6e20-111a-e063-dadaa90a10e2b95bad36-668d-0954-e053-2995a90ab0f3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70704-212-20burn solution cream1 in 1 BOXCREAM13
70704-212-20burn solution cream5.6 mL in 1 TUBECREAM5.63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70704-212BURN SOLUTION CREAM (TETRACAINE CREAM) CREAM [BURN SOLUTION FOUNDATIONS]3Legacy NDC, 2 package rows20210427_b95bad36-668d-0954-e053-2995a90ab0f3.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70704-21270704-212-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
WATER059QF0KO0RIACT
TETRACAINE0619F35CGVACTIB
WHITE WAX7G1J5DA97FIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM BORATE ANHYDROUS8191EN8ZMDIACT
LAURIC DIETHANOLAMIDEI29I2VHG38IACT
EUCALYPTUS OIL2R04ONI662IACT
PROPYLPARABENZ8IX2SC1OHIACT

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
c0e3c44c-b7bf-da89-e053-2a95a90a3482b95bad36-668d-0954-e053-2995a90ab0f32021-04-26WarningsExact identifier
spl id: c0e3c44c-b7bf-da89-e053-2a95a90a3482
spl set id: b95bad36-668d-0954-e053-2995a90ab0f3

Reported adverse events (FAERS/openFDA)#

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