OZ NATURALS ANTISEPTIC GEL HANDSANITIZER- alcohol gel

OZ NATURALS Antiseptic Gel Handsanitizer by

Drug Labeling and Warnings

OZ NATURALS Antiseptic Gel Handsanitizer by is a Otc medication manufactured, distributed, or labeled by OZ Naturals LLC, OZ NATURALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Antispetic Skin Cleanser

Use

Antiseptic skin cleanser to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

DIRECTIONS FOR USE:

Adults and children over 2 years
Supervise children when they use this product
For occasional and personal domestic use
Rub thoroughly into hands for at least 30 seconds. Allow to dry.

ACTIVE INGREDIENT

Ethyl Alcohol 70%p/p

WARNINGS:

For external use only

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water

Stop use and consult a health care professional if irritation develops

Keep out of reach of children

If swallowed, call a poison control center or get medical help right away

Flammable

Keep away from flames or heat source

Avoid temperature over 43°C (110°F)

Warnings

Keep out of reach of children

INACTIVE INGREDIENTS:

Aqua/Water/Eau, Glycerin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Citrus Paradisi (Grapefruit) Peel Oil, Carbomer, Triethanolamine

Distributed by OZNaturals®

319 Clematis St. Ste. 700,
West Palm Beach, FL 33401

MADE IN CANADA

Principal Display Panel

OZNATURALS Antiseptic Gel Hand Sanitizer

KILLS HARMFUL BACTERIA AND GERMS

INGREDIENTS AND APPEARANCE

OZ NATURALS ANTISEPTIC GEL HANDSANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75592-201
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CITRUS PARADISI FRUIT OIL (UNII: 6A7N43E0OJ)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TRIETHANOLAMINE ISOSTEARATE (UNII: T8OTU5ECY5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75592-201-01	1 in 1 BOX	04/16/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 75592-201-02	1 in 1 BOX	04/16/2020
2		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 75592-201-03	1 in 1 BOX	04/16/2020
3		475 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/16/2020

Labeler - OZ Naturals LLC (079726946)

Registrant - OZ Naturals LLC (079726946)

Establishment
Name	Address	ID/FEI	Business Operations
OZ NATURALS LLC		079726946	manufacture(75592-201) , pack(75592-201) , label(75592-201)