ASSURED INSTANT HAND SANITIZER- alcohol gel 
Gianthope Arts Product (Huizhou) Company Limited

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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Drug Facts

Active ingredient

Ethyl Alcohol 65% 

Purpose

 Antiseptic

Use

Warnings

For external use only.

Flammable,

Keep away from fire or flame

Do not apply around eyes, do not use in ears and mouth.

When using this product

avoid contact with eyes. In case of contact, rinse eyes with water immediately

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

Inactive ingredients

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance

Other information

Packaging

image description

ASSURED INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78524-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78524-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/02/2020
Labeler - Gianthope Arts Product (Huizhou) Company Limited (529306767)
Establishment
NameAddressID/FEIBusiness Operations
Gianthope Arts Product (Huizhou) Company Limited529306767manufacture(78524-002)

Revised: 6/2020
Document Id: 2757a4dc-3414-46e3-a7e3-569a7e86a971
Set id: 2b949b7c-70d9-439e-9dfb-552e2d1b34f0
Version: 1
Effective Time: 20200602
 
Gianthope Arts Product (Huizhou) Company Limited