FDA.reportPublic FDA data

Brazilian Heat

Manufacturer
Oxigenesis, Inc
Effective date
2018-03-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:01

Label at a glance#

ProductBrazilian Heat Brazilian Heat
Active ingredientMenthol
Label structure8 sections

Dosage and administration

Spray a light mist over the affected area up to 6 times daily. Allow to air dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Menthol 7.0%


Inactives

INACTIVE INGREDIENT SECTION

Alcohol, Dimethyl Sulfone (MSM),
Eucalyptus Oil, Gelidiella acerosa,
Hydrogen Peroxide and Chlorine
Dioxide, Hypnea musciformis,
Magnesium, Peppermint Oil,
Sargassum filipendula,
Sodium, Sorbitol, Water, Zinc

Purpose

OTC - PURPOSE SECTION

Purpose
External analgesic

Use

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain and soreness.
  • May help distract from pain.
  • May provide a cooling sensation.

Warnings

WARNINGS SECTION

Only for external use.

Flammable. Keep away from heat
or flame.

  • Do not apply to irritated skin or if
    excessive irritation develops
  • Avoid getting into the eyes or
    mucos membranes.

Directions

DOSAGE & ADMINISTRATION SECTION

Spray a light mist over the affected
area up to 6 times daily. Allow to
air dry.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product labelproduct label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086713menthol 7 % Topical SprayPSN1
1086713menthol 70 MG/ML Topical SpraySCD1
1086713menthol 7 % Topical SpraySY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72136-001-012022-01-28C16284748780-1d6a99b39-b730-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72136-001-01Brazilian HeatBrazilian Heat60 mL in 1 BOTTLE, WITH APPLICATORLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72136-001BRAZILIAN HEAT BRAZILIAN HEAT (MENTHOL) LIQUID [OXIGENESIS, INC]1Legacy NDC, 1 package rows20180328_0ec5cec8-d40b-4889-bcc8-bc7d49ed78da.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72136-00172136-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
EUCALYPTUS OIL2R04ONI662IACT
GELIDIELLA ACEROSAT91K54D6M1IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
CHLORINE DIOXIDE8061YMS4RMIACT
HYPNEA MUSCIFORMISW6FF9R1FJVIACT
MAGNESIUMI38ZP9992AIACT
PEPPERMINT OILAV092KU4JHIACT
SARGASSUM FILIPENDULA55P66J5H7NIACT
SODIUM9NEZ333N27IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
ZINCJ41CSQ7QDSIACT

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
1977c83c-6574-4998-85d3-83589f63b6120ec5cec8-d40b-4889-bcc8-bc7d49ed78da2018-03-27WarningsExact identifier
spl id: 1977c83c-6574-4998-85d3-83589f63b612
spl set id: 0ec5cec8-d40b-4889-bcc8-bc7d49ed78da

Reported adverse events (FAERS/openFDA)#

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