INSTANT HAND SANITIZER- alcohol gel 
Aero Healthcare

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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INSTANT HAND SANITIZER

Aero Healthcare

Drug Facts

Active Ingredients

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours.

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

Directions

Inactive ingredients

Aloe vera, carbomer, D&C green#5, D&C yellow #10, fragrance, purified water, triethanolamine

Manufactured for Aero Healthcare
63 Seaton St, Armidale, NSW 2350,
Email: sales@aerohealthcare.com
Ramsey, NJ 07446
www.aerohealthcare.us.com

PRINCIPAL DISPLAY PANEL – 2 fl. oz. Bottle Label

AERO
CLEANSE

INSTANT HAND SANITIZER

Moisturizing
Base with

Aloe Vera

60ml

2.0 fl.oz.

WATER-FREE

SOAP-FREE

RINSE-FREE

Contains: Ethyl Alcohol 66.5% v/v

Code: ACG060

MADE IN USA

PRINCIPAL DISPLAY PANEL – 2 fl. oz. Bottle Label

PRINCIPAL DISPLAY PANEL – 4 fl. oz. Bottle Label

AERO
CLEANSE

INSTANT HAND SANITIZER

Moisturizing
Base with

Aloe Vera

120ml

4.0 fl.oz.

WATER-FREE

SOAP-FREE

RINSE-FREE

Contains: Ethyl Alcohol 66.5% v/v

Code: ACG120

PRINCIPAL DISPLAY PANEL – 4 fl. oz. Bottle Label

PRINCIPAL DISPLAY PANEL – 8 fl. oz. Bottle Label

AERO
CLEANSE

INSTANT HAND SANITIZER

Moisturizing
Base with

Aloe Vera

240ml

8.0 fl.oz.

WATER-FREE

SOAP-FREE

RINSE-FREE

Contains: Ethyl Alcohol 66.5% v/v

Code: ACG240

PRINCIPAL DISPLAY PANEL – 8 fl. oz. Bottle Label
INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol0.665 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
carbomer interpolymer type a (55000 mpa.s) (UNII: 59TL3WG5CO)  
d&c green no. 5 (UNII: 8J6RDU8L9X)  
d&c yellow no. 10 (UNII: 35SW5USQ3G)  
water (UNII: 059QF0KO0R)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55305-111-1060 mL in 1 BOTTLE, PLASTIC
2NDC:55305-111-11120 mL in 1 BOTTLE, PLASTIC
3NDC:55305-111-12240 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/30/2013
Labeler - Aero Healthcare (008186174)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(55305-111)

Revised: 12/2013
Document Id: ae5c7e38-d112-4ff3-8757-aac3dc864848
Set id: e6aec5f6-672e-49d2-ae90-a1ee57c6c987
Version: 1
Effective Time: 20131230
 
Aero Healthcare