FDA.reportPublic FDA data

Kalaya Breathe Easy Ointment Vaporizing Rub

Manufacturer
Avaria Health & Beauty Corp
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:38:33

Label at a glance#

ProductKalaya Breathe Easy Vaporizing Rub
Active ingredientMENTHOL, CAMPHOR (NATURAL), EUCALYPTUS OIL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

activeactive

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of ReachKeep Out Of Reach

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

INACTIVE INGREDIENT SECTION

InactiveInactive

OTC - PURPOSE SECTION

PurposePurpose

INDICATIONS & USAGE SECTION

UsesUses

WARNINGS SECTION

warningwarning

WARNINGS AND PRECAUTIONS SECTION

warningswarnings

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Breathe EasyBreathe Easy

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43493-0004-12022-02-26C16284748780-19d75b9d0-753d-f424-e053-dadaa90a57ceKalaya Breathe Easy Ointment Vaporizing Rub
43493-0004-12022-02-26C16284748780-19d75b9d0-753d-f424-e053-dadaa90a57ceKalaya Breathe Easy Ointment Vaporizing Rub
43493-0004-12022-01-28C16284748780-19d75b9d0-753d-f424-e053-dadaa90a57ceKalaya Breathe Easy Ointment Vaporizing Rub
43493-0004-12022-01-28C16284748780-19d75b9d0-753d-f424-e053-dadaa90a57ceKalaya Breathe Easy Ointment Vaporizing Rub
43493-0004-12020-04-21C16284748780-19d75b9d0-753d-f424-e053-dadaa90a57ceKalaya Breathe Easy Ointment Vaporizing Rub
43493-0004-12020-04-21C16284748780-19d75b9d0-753d-f424-e053-dadaa90a57ceKalaya Breathe Easy Ointment Vaporizing Rub
43493-0004-12020-01-31C16284748780-19d75b9d0-753d-f424-e053-dadaa90a57ceKalaya Breathe Easy Ointment Vaporizing Rub
43493-0004-12020-01-31C16284748780-19d75b9d0-753d-f424-e053-dadaa90a57ceKalaya Breathe Easy Ointment Vaporizing Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43493-0004-1Kalaya Breathe Easy Vaporizing Rub60 g in 1 JAROINTMENT607
43493-0004-1Kalaya Breathe Easy Vaporizing Rub1 in 1 BOXOINTMENT17

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
43493-000443493-0004-1

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
C15-23 ALKANEJ3N6X3YK96IACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
PEPPERMINT OILAV092KU4JHIACT
WHITE WAX7G1J5DA97FIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
EUCALYPTUS OIL2R04ONI662ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-10-17full-release2026-06-01 00:28:33

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
Kalaya Breathe Easy Vaporizing RubVAPORIZING RUBAvaria Health & Beauty Corp7adf96b1-03af-a87b-e053-2a91aa0a45852025-10-08WarningsExact identifier
ndc (package): 43493-0004-1
ndc (product): 43493-0004
ndc11 (package): 43493000401
spl id: 40a7b59d-3579-288e-e063-6294a90ad1de
spl set id: 7adf96b1-03af-a87b-e053-2a91aa0a4585

Reported adverse events (FAERS/openFDA)#

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