Label: CODE Z KOREAN BLACKBERRY SANITIZER MIST- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 17, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

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

  • PURPOSE

    ■ 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 CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

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

  • WARNINGS

    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

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    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)
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