BREATHE DEEPLY- menthol rub cream

Breathe Deeply by

Drug Labeling and Warnings

Breathe Deeply by is a Otc medication manufactured, distributed, or labeled by Kelada Creative Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 10%

Eucalyptus oil .25%

PURPOSE

• When applied to chest and throat, temporarily relieves cough and congestions due to minor throat and bronchial irritation associated with the common cold, asthma, or bronchitis

DOSAGE & ADMINISTRATION

• Temporarily relieves itching and discomfort associated with irritation, inflammation, and rashes due to insect bites, stings, poison ivy, oak and sumac​​

WARNINGS

For external use only

Do not use other than as directed

When using this product

• avoid contact with eyes and mucous membranes
• do not apply to wounds or broken skin
• do not microwave, hear or add hot water

INACTIVE INGREDIENT

Organic sunflower oil, Beeswax, Spanish Rosemary essential oil, Natural Vitamin E

KEEP OUT OF REACH OF CHILDREN

Keep our of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

• When applied to chest and throat, temporarily relieves cough and congestions due to minor throat and bronchial irritation associated with the common cold, asthma, or bronchitis

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BREATHE DEEPLY 
menthol rub cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71157-0019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	170 g  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
WHITE WAX (UNII: 7G1J5DA97F)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ROSEMARY OIL (UNII: 8LGU7VM393)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71157-0019-1	90 mL in 1 CAN; Type 0: Not a Combination Product	01/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/09/2017

Labeler - Kelada Creative Group (014340121)

Registrant - Kelada Creative Group (014340121)

Establishment
Name	Address	ID/FEI	Business Operations
Kelada Creative Group		014340121	manufacture(71157-0019)