K.VI ZERO SANITIZER- ethanol gel 
HWAJIN BIO COSMETICS 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

ETHANOL 70% w/w

INACTIVE INGREDIENTS

Water, Glycerin, Aloe Vera Gel, Mulberry Root Extract, Carbomer, Triethanolamine, Fragrance

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 sanitizer to reduce bacteria on the skin.

Directions

• Apply product onto clean and dry hands.
• Rub hands together covering all surfaces of hands and fingers until it is absorbed.
• Children should be supervised when using.

Other information

• Store between 1-30°C (34-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

PACKAGE LABEL : K.vi-zero Sanitizer Gel

Image of tube

K.VI ZERO SANITIZER 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78394-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL35 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MORUS ALBA ROOT (UNII: CST1G9BZGD)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78394-030-0150 g in 1 TUBE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - HWAJIN BIO COSMETICS CO., LTD. (688012988)
Registrant - HWAJIN BIO COSMETICS CO., LTD. (688012988)
Establishment
NameAddressID/FEIBusiness Operations
HWAJIN BIO COSMETICS CO., LTD.688012988manufacture(78394-030)

Revised: 6/2020
Document Id: 203e31a2-19ee-4b6c-82a4-a58b9e0a0346
Set id: a10e3c7f-af6f-4efa-a780-49dce8770ac6
Version: 1
Effective Time: 20200619
 
HWAJIN BIO COSMETICS CO., LTD.