INSTANT HAND SANITIZER- alcohol spray 
National Design 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.

----------

Instant hand sanitizer

Drug Facts

Active ingredient:

Ethyl Alcohol 68%

Purpose:

Antiseptic

Uses:

Warnings:

Flammable, Keep away from fire and flame.

For external use only

When using this product:

do not use in or near eyes, in case of contact, rinse eyes thoroughly with water.

Keep out of reach of children

Directions:

Place product on hands, rub untill dry

Ingreidients:

Glycerin, propylene glycol, triethanolamine, carbomer, fragrance, disodium edta,tocopheryl acetate, deionized water.

Package Labeling:

Bottle7

INSTANT HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80575-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.68 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80575-003-0120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/01/2020
Labeler - National Design LLC (360763320)

Revised: 9/2020
Document Id: b079067c-9487-51a2-e053-2a95a90a9edd
Set id: b079067c-9488-51a2-e053-2a95a90a9edd
Version: 1
Effective Time: 20200929
 
National Design LLC