ASSURED INSTANT HAND SANITIZER- alcohol gel

Assured Instant Hand Sanitizer by

Drug Labeling and Warnings

Assured Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Gianthope Arts Product (Huizhou) Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol 65% 

Purpose

 Antiseptic

Use

• 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 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

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

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Other information

• Store between 68-77℉ (20-25℃)
• May discolor fabrics.

Packaging

INGREDIENTS AND APPEARANCE

ASSURED INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78524-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78524-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/02/2020

Labeler - Gianthope Arts Product (Huizhou) Company Limited (529306767)

Establishment
Name	Address	ID/FEI	Business Operations
Gianthope Arts Product (Huizhou) Company Limited		529306767	manufacture(78524-002)