HAND SANITIZER 80 ALCOHOL- alcohol gel

Hand Sanitizer 80 Alcohol by

Drug Labeling and Warnings

Hand Sanitizer 80 Alcohol by is a Otc medication manufactured, distributed, or labeled by Aruba Aloe Balm NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Alcohol 80%

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

In children less than 2 months of age
On open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop using and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water (Aqua/Eau), Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Tocopheryl Acetate (Vitamin E Acetate), Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Sodium Hydroxide.

Package Labeling:

INGREDIENTS AND APPEARANCE

HAND SANITIZER 80 ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-185-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/30/2020

Labeler - Aruba Aloe Balm NV (855442273)

Establishment
Name	Address	ID/FEI	Business Operations
Aruba Aloe Balm NV		855442273	manufacture(53675-185)