CRAZY AARONS HAND SANITIZER 68% ALCOHOL- alcohol hand sanitizer gel

Crazy Aarons Hand Sanitizer 68% Alcohol by

Drug Labeling and Warnings

Crazy Aarons Hand Sanitizer 68% Alcohol by is a Otc medication manufactured, distributed, or labeled by Crazy Aaron Enterprises, Inc., B & J Group, Action-Pak, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredient

Ethanol 68% v/v

Purpose

Antiseptic

Use

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 fire or flame.

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use 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.

• on open skin wounds
• on children less than 2 months of age

Directions

Place enough product on hands to cover all surfaces. Rub hands together briskly 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

Ammonium Polyacryloyldimethyl Taurate, Blue 1, Calcium Sodium Borosilicate, Carmine, Fragrance, Glycerin, Mica, Propylene Glycol, Silica, Tin Oxide, Titanium Dioxide, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CRAZY AARONS HAND SANITIZER 68% ALCOHOL 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80032-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
BOROSILICATE GLASS (UNII: BOJ6T9AR90)
MICA (UNII: V8A1AW0880)
DIBUTYLTIN OXIDE (UNII: T435H74FO0)
COBALT TITANIUM OXIDE (UNII: CN422GY0TE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
3-(NONYLOXY)1,2-PROPANEDIOL (UNII: 73E9M7IT67)
COCHINEAL (UNII: TZ8Z31B35M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80032-400-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/20/2020

Labeler - Crazy Aaron Enterprises, Inc. (092666531)

Registrant - Crazy Aaron Enterprises, Inc. (092666531)

Establishment
Name	Address	ID/FEI	Business Operations
B & J Group		064604222	manufacture(80032-400)

Establishment
Name	Address	ID/FEI	Business Operations
Action-Pak, Inc.		117537305	relabel(80032-400) , repack(80032-400)