Breathiezzz

Manufacturer
Fortunique B.V.
Effective date
2016-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:12

Label at a glance#

ProductBreathiezzz
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM
Label structure14 sections

Indications and uses

On chest and throat, temporarily relieves coungh due to common cold On muscles and joints, temporarily relieves minor aches and pains

Dosage and administration

See important warnings under " When using this product" Adults and children 2 years and over: roll layer on chest & throat or roll on sore aching muscles. Cover with a warm, dry cloth if desired. Keep clothing loose around throat /chest to help vapors reach the nose/mouth. Repeat up to three times per 24 hours or as directed by doctor. Children under 2 years: do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 5%

Menthol 2.75%

Purpose

DOSAGE & ADMINISTRATION SECTION

Cough Suppressant/Topical Analgesic

Uses

OTC - PURPOSE SECTION

On chest and throat, temporarily relieves coungh due to common cold

On muscles and joints, temporarily relieves minor aches and pains

Warning

WARNINGS SECTION

For external use only

Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

By mouth. With tinght bandages

In nostrils. On wounds or damaged skin

Ask a Doctor before use if you have

OTC - ASK DOCTOR SECTION

Cough that occurs with to much phlegm(mucus). Persistent or chronic cough such as occurs within smoking, asthma or emphysema

When using this product, do not

OTC - WHEN USING SECTION

Heat. Microwave. Add to hot water or any container where heating water. May cause splattering and result in burns

Stop use and ask a Doctor if

OTC - STOP USE SECTION

Muscle aches and pains persist more than 7 days or come back. Cough lasts more than 7 days, comes back occurs with fever, rash or persistent headache .

These could be signs of a serious condition

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

INDICATIONS & USAGE SECTION

See important warnings under " When using this product"

Adults and children 2 years and over: roll layer on chest & throat or roll on sore aching muscles. Cover with a warm, dry cloth if desired. Keep clothing loose around throat /chest to help vapors reach the nose/mouth. Repeat up to three times per 24 hours or as directed by doctor. Children under 2 years: do not use

Other information

INSTRUCTIONS FOR USE SECTION

Store at room temperature below 77º F

No added coloring agent and fragrance

Paraben and preservative free

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglycerides

Eucalyptol

Principle Display Panel. 10ml tube with applicator. Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Breathiezzz CartonBreathiezzz Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70359-4107-12020-01-31C16284748780-19d75b9d0-1900-f424-e053-dadaa90a57ce29e2f4af-d9d4-0995-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70359-4107-1Breathiezzz1 in 1 CARTONOIL12
70359-4107-1Breathiezzz10 g in 1 TUBE, WITH APPLICATOROIL102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70359-4107BREATHIEZZZ (CAMPHOR,MENTHOL) OIL [FORTUNIQUE B.V.]2Legacy NDC, 2 package rows20161217_29e2f4af-d9d4-0995-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70359-410770359-4107-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
43a476ab-fad8-4302-e054-00144ff8d46c29e2f4af-d9d4-0995-e054-00144ff88e882016-12-14WarningsExact identifier
spl id: 43a476ab-fad8-4302-e054-00144ff8d46c
spl set id: 29e2f4af-d9d4-0995-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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