LEMON SANITIZING COLOGNE- alcohol spray

Lemon Sanitizing Cologne by

Drug Labeling and Warnings

Lemon Sanitizing Cologne by is a Otc medication manufactured, distributed, or labeled by L3VEL3 LLC, KOZMOTEK PAZARLAMA KOZMETIK ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Sanitizing Cologne

Description

Refreshing and energizing, the LEVEL3 Lemon Cologne delivers a fresh and aromatic citrus fragrance. The scent combines lemon and a sweet smell of vanilla, producing an elegant and revitalizing aroma that is perfect for any occasion.

Directions:

Apply to clean and dry skin. Pour a small amount of cologne on your palm or fingers and dab gently on the desired areas.

Warnings

For external use only. Flammable. Do not use near heat or open flame. Avoid Contact with Eyes. In case of contact with eyes, rinse with plenty of water. Keep out of the reach of children. Keep in a cool place protected from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

Active Ingredient(s)

Alcohol

Inactive ingredients

Aqua, Parfum, Coumarin, Limonene, Hydroxycitronellal, Alpha-Isomethyl Ionone, Linalool

Package Label - Principal Display Panel

250 mL NDC: 80848-003-01

INGREDIENTS AND APPEARANCE

LEMON SANITIZING COLOGNE 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80848-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LINALOOL, (+/-)- (UNII: D81QY6I88E)	0.016 mL  in 100 mL
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)	0.032 mL  in 100 mL
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)	0.025 mL  in 100 mL
COUMARIN (UNII: A4VZ22K1WT)	0.045 mL  in 100 mL
LIMONENE, (+/-)- (UNII: 9MC3I34447)	0.039 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80848-003-01	250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/15/2020

Labeler - L3VEL3 LLC (128877852)

Establishment
Name	Address	ID/FEI	Business Operations
KOZMOTEK PAZARLAMA KOZMETIK ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI		505246218	manufacture(80848-003)