MENTHOL by EROS GLOBAL CORP / CHEMCO CORPORATION 80465-002-04

MENTHOL by

Drug Labeling and Warnings

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

Drug Details [pdf]

MENTHOL- menthol liquid 
EROS GLOBAL CORP

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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80465-002-04

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 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80465-002
Route of Administration	NASAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80465-002-04	113 g in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/21/2020

Labeler - EROS GLOBAL CORP (117597821)

Registrant - CHEMCO CORPORATION (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMCO CORPORATION		032495954	manufacture(80465-002)

Revised: 6/2022

Document Id: e2881878-f26a-84e9-e053-2a95a90a24cb

34390-5

Set id: afd80a8b-e829-439c-e053-2a95a90a9c3b

Version: 3

Effective Time: 20220628