BREATHIEZZZ- camphor,menthol oil

Breathiezzz by

Drug Labeling and Warnings

Breathiezzz by is a Otc medication manufactured, distributed, or labeled by Fortunique B.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Camphor 5%

Menthol 2.75%

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 77º F

No added coloring agent and fragrance

Paraben and preservative free

Inactive Ingredients

Caprylic/Capric Triglycerides

Eucalyptol

Principle Display Panel. 10ml tube with applicator. Carton

INGREDIENTS AND APPEARANCE

BREATHIEZZZ 
camphor,menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70359-4107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2.75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EUCALYPTOL (UNII: RV6J6604TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70359-4107-1	1 in 1 CARTON	01/21/2016
1		10 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/21/2016

Labeler - Fortunique B.V. (407788616)

Registrant - Fortunique B.V. (407788616)

Establishment
Name	Address	ID/FEI	Business Operations
Fortunique B.V.		407788616	manufacture(70359-4107)