LUXE AND WILLOW HAND SANITIZER- alcohol gel 
MiWorld Accessories 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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Luxe & Willow Hand Sanitizer Gel

Drug Facts

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

Warnings

For external use only. Only on hands.

Flammable, keep away from fire or flame.

Do not use

in or near eyes. In case of contact, rinse thoroughly with water

Stop use and ask a doctor 

if irritation and redness develop and persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Aqua, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate

Package Labeling:

Label

LUXE AND WILLOW HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78713-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETOL (UNII: Q4R969U9FR)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78713-002-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - MiWorld Accessories LLC (078708128)

Revised: 7/2020
Document Id: aaa7bb64-c442-141d-e053-2995a90a2638
Set id: aaa72cb4-2742-3418-e053-2995a90aca20
Version: 1
Effective Time: 20200717
 
MiWorld Accessories LLC