ZEROTH PREMIUM HAND SANITIZER- alcohol gel 
Biocleansingcompany Co., Ltd

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

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

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

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

• instant hand antiseptic to decrease bacteria on the skin

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 1-30C (39-86F)
• Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

ZEROTH PREMIUM HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78393-010
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
Water (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EDETOL (UNII: Q4R969U9FR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
BEACH STRAWBERRY (UNII: 98542F2TQS)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
MORUS ALBA BARK (UNII: 7O71A48NDP)  
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)  
GRAPEFRUIT (UNII: O82C39RR8C)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78393-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - Biocleansingcompany Co., Ltd (695538805)
Registrant - Biocleansingcompany Co., Ltd (695538805)
Establishment
NameAddressID/FEIBusiness Operations
DongbangCosmetics Co., ltd.694452564manufacture(78393-010)

Revised: 5/2020
Document Id: 256f2984-2afe-4ff4-acd1-4a841d185f6e
Set id: 8a984f5f-d3a6-458b-8b39-90767d548c0b
Version: 1
Effective Time: 20200527
 
Biocleansingcompany Co., Ltd