MENTHOL by NATURAL 17 / CHEMCO CORPORATION 80770-002-04

MENTHOL by

Drug Labeling and Warnings

MENTHOL by is a Otc medication manufactured, distributed, or labeled by NATURAL 17, CHEMCO CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MENTHOL- menthol spray 
NATURAL 17

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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80770-002-04

Mist on a handkerchief or pillow, apply directly on chest or back, or spray in the air.

For external use only.

Avoid contact with eyes.

Keep away from flame. Flammable.

Alcohol Denat., Aqua, Eucalyptus Globulus Leaf Oil, Isopropyl Alcohol, Propylene Glycol, Parfum, Polysorbate 20, Geraniol, Citronellol, Hydroxycitronellal, Linalool, Coumarin.

Breathe Easy Spray is enriched with a blend of refreshing essential oils to clear the senses, restore free breathing, and purify the air. The soothing blend of eucalyptus essential oil and menthol helps ease nasal congestion symptoms.

Keep out of children’s reach.

Analgesic

Menthol …………………………………………...………………….……... 2%

MENTHOL 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80770-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)	Â
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)	Â
WATER (UNII: 059QF0KO0R)	Â
ISOPROPYL ALCOHOL (UNII: ND2M416302)	Â
GERANIOL (UNII: L837108USY)	Â
LINALOOL, (+)- (UNII: F4VNO44C09)	Â
COUMARIN (UNII: A4VZ22K1WT)	Â
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)	Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80770-002-04	113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/19/2020	03/27/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/19/2020	03/27/2025

Labeler - NATURAL 17 (103497833)

Registrant - CHEMCO CORPORATION (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMCO CORPORATION		032495954	manufacture(80770-002)

Revised: 9/2023

Document Id: 04de21db-3ccf-fe30-e063-6394a90aadd5

34390-5

Set id: b20a7bd2-2b78-7265-e053-2995a90ad7b5

Version: 3

Effective Time: 20230908

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