INSTANT HAND SANITIZER- alcohol gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Aero Healthcare, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

INSTANT HAND SANITIZER

Aero Healthcare

Drug Facts

Active Ingredients

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

• for handwashing to decrease bacteria on skin
• recommended for repeated use

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

• wet hands thoroughly with product
• allow to dry without wiping
• children under 6 should be supervised while using this product

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 – 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 – 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

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55305-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	0.665 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55305-111-10	60 mL in 1 BOTTLE, PLASTIC
2	NDC: 55305-111-11	120 mL in 1 BOTTLE, PLASTIC
3	NDC: 55305-111-12	240 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/30/2013

Labeler - Aero Healthcare (008186174)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(55305-111)