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 Gel

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do 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, Acrylates Copolymer, Trimethylene Glycol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Triethanolamine

Other Information

Store below 104°F (40°C)
May discolor certain fabrics or surfaces

Product Label

ACG120_4oz ACG240_8oz ACG500_16oz ACG1000_1L ACG3785 1 Gal

AEROCLEANSE HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55305-131
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55305-131-01	237 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/26/2020
2	NDC:55305-131-02	3780 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/26/2020
3	NDC:55305-131-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2020
4	NDC:55305-131-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2020
5	NDC:55305-131-05	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2020
6	NDC:55305-131-06	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/26/2020

Labeler - Aero Healthcare US LLC (008186174)

Registrant - Aero Healthcare US LLC (008186174)