Aruba Aloe Hand Sanitizer 80% Alcohol

Aruba Aloe Hand Sanitizer 80% Alcohol by

Drug Labeling and Warnings

Aruba Aloe 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]

ARUBA ALOE HAND SANITIZER 80% ALCOHOL- alcohol gel 
Aruba Aloe Balm NV

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Aruba Aloe Hand Sanitizer 80% Alcohol

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

• On 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 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

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), Aminomethyl Propanol.

Package Labeling:

ARUBA ALOE HAND SANITIZER 80% ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-192
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)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-192-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2020	02/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	09/15/2020	02/29/2024

Labeler - Aruba Aloe Balm NV (855442273)

Establishment
Name	Address	ID/FEI	Business Operations
Aruba Aloe Balm NV		855442273	manufacture(53675-192)

Revised: 3/2024

Document Id: 129ab5fb-9497-a510-e063-6394a90ad81b

34390-5

Set id: ec61c74f-55ad-4e57-b1ac-6005f98e27cd

Version: 3

Effective Time: 20240301