AeroCleanse Hand Sanitizer 72%

AeroCleanse Hand Sanitizer by

Drug Labeling and Warnings

AeroCleanse Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Aero Healthcare US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AEROCLEANSE HAND SANITIZER- hand sanitizer gel 
Aero Healthcare US LLC

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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AeroCleanse Hand Sanitizer 72%

Active Ingredient

Ethyl Alcohol 72% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to reduce bacteria on the skin

Warnings

Flamable. Keep away from fire or flame.
​For external use only

When using this product don not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product in your palm to thoroughly cover your hands.

Rub hands together briskly until dry.

Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, C10-30 Alkyl Acrylate Crosspolymer, Isopropyl Alcohol, Methyl Gluceth-20, Trimethylene Glycol, Tocopheryl Acetate, Aminomethyl Propanol.

Other Information

Store Below 104° F (40°C)

May discolor certain fabrics or surfaces.

Product Label

AEROCLEANSE HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55305-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.72 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55305-132-01	474 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/28/2021	03/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/28/2021	03/31/2022

Labeler - Aero Healthcare US LLC (008186174)

Registrant - Aero Healthcare US LLC (008186174)

Establishment
Name	Address	ID/FEI	Business Operations
Aero Healthcare US LLC		008186174	pack(55305-132)

Revised: 4/2022

Document Id: ddceeead-2ca9-2e5a-e053-2a95a90a2387

34390-5

Set id: c3693cde-2ed9-7051-e053-2995a90a0a9f

Version: 2

Effective Time: 20220429