Label: LUCK-LADY ALCOHOL WIPES- 75% alcohol wipes 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 August 12, 2020

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  • ACTIVE INGREDIENT

    Alcohol 75% v/w

    Benzalkonium Chloride <1% w/w

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Used for antibacterial hand skin, prevent bacteria.

  • WARNINGS

    For external use only. Flammable. Keep away from fire.

  • DO NOT USE

    • Keep away from fire.
    • Do not wipe your eyes.
    • Do not throw into the toilet (not soluble in water).

  • WHEN USING

    • Please wait until the alcohol has completely evaporated after wiping.
    • Before use, check whether the packaging is intact. Do not use if it is damaged.

  • STOP USE

    Stop use and ask a doctor for those with alcohol allergy or sensitive skin.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • STORAGE AND HANDLING

    • Store between 15-30°C (59-86°F).
    • Avoid freezing and excessive heat above 40°C (104°F).

  • INACTIVE INGREDIENT

    Purified water, Cocamidopropyl PG-Dimonium Chloride Phosphate,
    Stearyldimoniumhydroxypropyl Laurylglucosides Chloride

  • DOSAGE & ADMINISTRATION

  • PRINCIPAL DISPLAY PANEL

    1 piece inner package

    Luck-Lady Alcohol Wipes_package50 pieces package

  • INGREDIENTS AND APPEARANCE
    LUCK-LADY ALCOHOL WIPES 
    75% alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79366-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARYLDIMONIUMHYDROXYPROPYL LAURYLGLUCOSIDES CHLORIDE (UNII: ONN0OB7U86)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79366-104-0150 in 1 PACKET08/12/2020
    15.2 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:79366-104-50260 g in 1 POUCH; Type 0: Not a Combination Product08/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/12/2020
    Labeler - Dong Hiep Trading and Investment Co., Ltd (555728654)
    Registrant - Dong Hiep Trading and Investment Co., Ltd (555728654)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong Hiep Trading and Investment Co., Ltd555728654manufacture(79366-104)
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