Aruba Aloe Hand Sanitizer Spray 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 spray 
Aruba Aloe Balm NV

----------

Aruba Aloe Hand Sanitizer Spray 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), Fragrance (Parfum), Citric Acid.

Package Labeling:59ml

Bottle2

Package Labeling:237ml

Bottle3

ARUBA ALOE HAND SANITIZER 80% ALCOHOL 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53675-193
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53675-193-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/202002/29/2024
2NDC: 53675-193-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/202002/29/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)09/15/202002/29/2024
Labeler - Aruba Aloe Balm NV (855442273)

Revised: 3/2024
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.