Active Ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Uses[s]

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 heat or flame.

Do not use

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

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 Center right away.

Directions

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

Deionized Water, Glycerin, Propylene Glycol, Organic Aloe Barbadensis (Aloe Vera) Leaf Extract, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E Acetate), Carbomer, Aminomethyl Propanol

Hand Sanitizer Gel Pail (5 Gallons) Hand Sanitizer Gel Drum (55 Gallons) Hand Sanitizer Gel Tank (Tote) Hand Sanitizer Gel 8oz Hand Sanitizer Gel Gallon

ESSENTIALS BY CATALINA HAND SANITIZER GEL
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76902-027
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	25.852 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.841 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.381 mL in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	0.007 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	0.009 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.373 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.009 g in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	1.515 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76902-027-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/04/2020
2	NDC:76902-027-02	3785 mL in 1 JUG; Type 0: Not a Combination Product	06/04/2020
3	NDC:76902-027-03	18927 mL in 1 PAIL; Type 0: Not a Combination Product	06/04/2020
4	NDC:76902-027-04	208197 mL in 1 DRUM; Type 0: Not a Combination Product	06/04/2020
5	NDC:76902-027-05	1040987 mL in 1 TANK; Type 0: Not a Combination Product	06/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/04/2020

Labeler - Maki Creations (080478763)

Name	Address	ID/FEI	Business Operations
Establishment
Maki Creations, Inc.		080478763	manufacture(76902-027)

Essentials by Catalina Hand Sanitizer Gel