Label: JNN-II CLEAN-L SAFE HAND WIPES- alcohol cloth

  • 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 September 24, 2020

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    Safe Hand Wipes

    Active ingredient

    Alcohol 70% w/w

    Purpose

    Antiseptic

    Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    ■ in children less than 2 months of age ■ on open skin wounds

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    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.

    Directions

    ■ Remove the wipes one by one and use on the skin gently.

    ■ There is a risk of contamination if the wet wipe is put back into the packaging with unclean hands.

    ■ Do not throw away wipes in a flush toilet, as there is a risk of clogging it.

    ■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)

    Other information

    ■ Store between 15-30 °C (59-86 °F)

    ■ Avoid freezing and excessive heat above 40 °C (104 °F)

    Inactive ingredients

    Water, Glycerin, Butylene Glycol, Methylpropanediol, Fragrance, Menthol, Caprylhydroxamic Acid, Sodium Coco PG-Dimonium Chloride Phosphate, Sodium Levulinate, Levulinic Acid, Laurylpyridinium Chloride, Glyceryl Laurate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Camellia Sinensis Leaf Extract, 1,2-Hexanediol, Sodium Hyaluronate, Maltodextrin

  • INGREDIENTS AND APPEARANCE
    JNN-II CLEAN-L SAFE HAND WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78424-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2.625 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    MENTHOL (UNII: L7T10EIP3A)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78424-070-2020 in 1 PACKET; Type 0: Not a Combination Product09/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/2020
    Labeler - JOY LIFE Co., Ltd. (689846233)
    Establishment
    NameAddressID/FEIBusiness Operations
    JOY LIFE Co., Ltd.689846233manufacture(78424-070)