LEMON SANITIZING COLOGNE- alcohol spray 
L3VEL3 LLC

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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Lemon Sanitizing Cologne

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 the reach of children.

Active Ingredient(s)

Alcohol

Inactive ingredients

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

Package Label - Principal Display Panel

Lemon Sanitizing Cologne 250ml Label250 mL NDC: 80848-003-01

LEMON SANITIZING COLOGNE 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80848-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80848-003-01250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/15/2020
Labeler - L3VEL3 LLC (128877852)
Establishment
NameAddressID/FEIBusiness Operations
KOZMOTEK PAZARLAMA KOZMETIK ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI505246218manufacture(80848-003)

Revised: 10/2020
Document Id: b1cd5106-3bf4-2143-e053-2a95a90ab592
Set id: b1bbfb15-6775-5563-e053-2995a90a37a1
Version: 2
Effective Time: 20201016
 
L3VEL3 LLC