O2 CLEAN HAND SANITIZER- alcohol gel 
O2 Clean

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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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

Image of bottle

O2 CLEAN HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80453-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80453-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - O2 Clean (694888055)
Registrant - O2 Clean (694888055)
Establishment
NameAddressID/FEIBusiness Operations
DongbangCosmetics Co., ltd.694452564manufacture(80453-010)

Revised: 9/2020
Document Id: 67a98b42-d1c8-480b-b2e4-873492682882
Set id: 35ab90e2-bc8f-472b-8bd2-201aac059f02
Version: 1
Effective Time: 20200915
 
O2 Clean