CODE Z KOREAN BLACKBERRY SANITIZER MIST- alcohol liquid 
K CLEANTECH 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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Drug Facts

alcohol

WATER, fragrance, sodium hyaluronate, aloe vera extract, 1,2-hexanediol, octocrylene, CI 17200, CI 60730

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic to decrease bacteria on the skin

KEEP OUT OF REACH OF THE CHILDREN

Apply an appropriate amount on your hands and rub well until dry.

1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and ears, in the oral cavity (may have irritating effects)
2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms

for external use only

label

CODE Z KOREAN BLACKBERRY SANITIZER MIST 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80079-0004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
OCTOCRYLENE (UNII: 5A68WGF6WM)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80079-0004-140 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/15/2020
Labeler - K CLEANTECH CO., LTD. (695519626)
Registrant - K CLEANTECH CO., LTD. (695519626)
Establishment
NameAddressID/FEIBusiness Operations
BELLESON Inc.694793004manufacture(80079-0004)
Establishment
NameAddressID/FEIBusiness Operations
K CLEANTECH CO., LTD.695519626label(80079-0004)

Revised: 8/2020
Document Id: ad0d2d07-75fd-2bea-e053-2a95a90a6385
Set id: ad0d266a-584a-23a3-e053-2a95a90af73e
Version: 1
Effective Time: 20200817
 
K CLEANTECH CO., LTD.