O2 CLEAN HAND SANITIZER- alcohol gel

O2 CLEAN HAND SANITIZER by

Drug Labeling and Warnings

O2 CLEAN HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by O2 Clean, DongbangCosmetics Co., ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 70% v/v

INACTIVE INGREDIENTS

Acorus Calamus Root Extract, Camellia Sinensis Leaf Extract, Carbomer, Citrus Paradisi (Grapefruit) Fruit Extract, Cnidium Officinale Rhizome Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Oil, Morus Alba Bark Extract, Sophora Angustifolia Root Extract, Tetrahydroxypropyl Ethylenediamine, Tocopheryl Acetate, Water

PURPOSE

Hand Sanitizer

WARNINGS

For external use only.

Flammable. Keep away from heat or flame

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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Can be used anytime and has effective Sterilization

Directions

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
Supervise children in the use of this product.

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
* Keep out of direct light and store in a cool, dry area

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

O2 CLEAN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80453-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	Alcohol	350 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GRAPEFRUIT (UNII: O82C39RR8C)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
BEACH STRAWBERRY (UNII: 98542F2TQS)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MORUS ALBA BARK (UNII: 7O71A48NDP)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
EDETOL (UNII: Q4R969U9FR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80453-010-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - O2 Clean (694888055)

Registrant - O2 Clean (694888055)

Establishment
Name	Address	ID/FEI	Business Operations
DongbangCosmetics Co., ltd.		694452564	manufacture(80453-010)