ESSENTIALS BY CATALINA HAND SANITIZER- alcohol liquid
Maki Creations, Inc.

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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Essentials by Catalina Hand Sanitizer Gel

Active Ingredients[s]

Alcohol 70% v/v

Purpose

Antiseptic

Use[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 thoroughtly 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.

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

275 Gallon Tank (Tote) of Hand Sanitizer 55 Gallon Drum of Hand Sanitizer 5 Gallon Pail of Hand Sanitizer 1 Gallon Jug of Hand Sanitizer 8 oz Bottle of Hand Sanitizer

ESSENTIALS BY CATALINA HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76902-025
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
POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU)	0.62 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.18 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.8 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.32 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.02 mL in 100 mL
WATER (UNII: 059QF0KO0R)	27.06 mL in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	0.01 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	0.01 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76902-025-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
2	NDC:76902-025-02	3785 mL in 1 JUG; Type 0: Not a Combination Product	05/11/2020
3	NDC:76902-025-03	18927 mL in 1 PAIL; Type 0: Not a Combination Product	05/11/2020
4	NDC:76902-025-04	208197 mL in 1 DRUM; Type 0: Not a Combination Product	05/11/2020
5	NDC:76902-025-05	1040987 mL in 1 TANK; Type 0: Not a Combination Product	05/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/11/2020

Labeler - Maki Creations, Inc. (080478763)

Name	Address	ID/FEI	Business Operations
Establishment
Maki Creations, Inc.		080478763	manufacture(76902-025)