AMORAY PREMIUM HAND SANITIZER- alcohol gel 
My Imports USA 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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Amoray Premium Hand Sanitizer

Drug Facts

Active ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

•Hand sanitizer to help decrease bacteria on the skin. •When water, soap & towel are not available. •Recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from fire or flame. Do not apply around eyes.

Do not use

in ears & mouth.

When using this product,

avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if

redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

Directions

•Pump as needed into your palms and thoroughly spread on both hands. •Rub into skin until dry.

Other information

•Store at 20°C (68 to 77°F).•May discolor fabrics.

Inactive ingredients

•Water, triethanolamine, glycerin, carbomer, PEG-40 hydrogenated castor oil, propylene glycol, fragrance, tocopheryl acetate, aloe barbadensis gel.

Package Labeling:

Bottle

AMORAY PREMIUM HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-4221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51628-4221-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/29/2020
Labeler - My Imports USA LLC (195767988)

Revised: 10/2020
Document Id: b1a1bbe0-d72c-759a-e053-2995a90a9574
Set id: abab3301-990c-41cc-e053-2a95a90a2980
Version: 2
Effective Time: 20201014
 
My Imports USA LLC