Rosemary Yuzu Sanitizer by Cleanli Brands LLC / MYKU Biosciences LLC

Rosemary Yuzu Sanitizer by

Drug Labeling and Warnings

Rosemary Yuzu Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cleanli Brands LLC, MYKU Biosciences LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROSEMARY YUZU SANITIZER- ethyl alcohol spray 
ROSEMARY YUZU SANITIZER- ethyl alcohol liquid 
Cleanli Brands 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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Active Ingredient(s) Purpose

Ethyl Alcohol 63% †..........................................Antiseptic

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Do not use

in children less than 2 months of age on open skin wounds

Inactive Ingredients

Water, Glycerin, Rosemary Oil, Mixed Tocopherols, Green Mandarin Oil, Yuzu Oil

Uses

Hand Sanitizer to help reduce bacteria tha can potentially cause disease. For use when soap and water are not available.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away 1-800-222-1222

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

When using this product

keep out of eyes, ears, and mouth. In case pf contact with eyes, rinse eyes thoroughly with water.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using the product to avoid swallowing.

Cleanli Rosemary Yuzu Sanitizer 30mL

Principal Display Label 1G

ROSEMARY YUZU SANITIZER 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80708-325
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ROSEMARY (UNII: IJ67X351P9) 1 mL  in 100 mL
TOCOPHEROL (UNII: R0ZB2556P8) 0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 33.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
MANDARIN OIL (UNII: NJO720F72R) 0.4 mL  in 100 mL
CITRUS JUNOS FRUIT OIL (UNII: 20H47327KQ) 0.4 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80708-325-3030 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/16/202003/01/2022
ROSEMARY YUZU SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80708-326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ROSEMARY (UNII: IJ67X351P9) 1 mL  in 100 mL
TOCOPHEROL (UNII: R0ZB2556P8) 0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 33.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
MANDARIN OIL (UNII: NJO720F72R) 0.4 mL  in 100 mL
CITRUS JUNOS FRUIT OIL (UNII: 20H47327KQ) 0.4 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80708-326-184000 mL in 1 JUG; Type 0: Not a Combination Product11/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/16/202003/01/2022
Labeler - Cleanli Brands LLC (117661441)
Establishment
NameAddressID/FEIBusiness Operations
MYKU Biosciences LLC106728135manufacture(80708-325, 80708-326)

Revised: 3/2022
 

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