Active Ingredients
Camphor 5%
Menthol 2.75%
Breathiezzz
FDA Label NDC 70359-4107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fortunique B.v. for the product Breathiezzz (NDC 70359-4107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warning, do not use, ask a doctor before use if you have, when using this product, do not, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough Suppressant/Topical Analgesic
Uses
On chest and throat, temporarily relieves coungh due to common cold
On muscles and joints, temporarily relieves minor aches and pains
Warning
For external use only
Avoid contact with eyes
Do Not Use
By mouth. With tinght bandages
In nostrils. On wounds or damaged skin
Ask A Doctor Before Use If You Have
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
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
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
Ask a health professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
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
Store at room temperature below 77° F
No added coloring agent and fragrance
Paraben and preservative free
Inactive Ingredients
Caprylic/Capric Triglycerides
Eucalyptol
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