Label: E-PU PREMIUM MANDARIN HAND SANITIZING SERUM- ethyl alcohol lotion

  • 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 June 24, 2020

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

  • Active Ingredient(s)

    Alcohol 62% v/v. Purpose: Antiseptic

    Active Ingredient(s)

  • Purpose

    Antiseptic

    Purpose

  • Use

    Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

    Use

  • Warnings

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

    Warning

  • Do not use

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

    Do not use

  • When using this product

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

    When using this product

  • Stop use and ask a doctor

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Stop use and ask a doctor

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

    Directions

  • Other information

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

    Other Information

  • Inactive ingredients

    Water, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Acrylates Copolymer, Fragrance, Carbomer, Aminomethyl Propanol, Styrene/Acrylates Copolymer, Olea Europaea (Olive) Fruit Oil, Panthenol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Macadamia Ternifolia Seed Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Sodium Hyaluronate

    Inactive ingredients

  • Package Label - Principal Display Panel


    E-PU
    2 in 1
    Premium Mandarin
    Hand Sanitizing Serum
    62% Ethyl Alcohol as recommended
    2 in 1 Hand Sanitizer & Moisturizing Hand Serum
    E-PU Premium 2 in 1 Hand Sanitizing Serum is
    formulated with Natural Fragrance, Mandarin
    Zest and Herbal Oils, complying with ISO 9235.
    Helps reduce bacteria, while leaving your hand
    feeling refreshed, soft and clean. Enriched with
    Olive Fruit Oil, Sodium Hyaluronate & Aloe Vera
    which help to leave your hands fully moisturized
    and hydrated even after sanitizing.
    100ml / 3.38 fl.oz.

    Package Label - Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    E-PU PREMIUM MANDARIN HAND SANITIZING SERUM 
    ethyl alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73862-218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73862-218-1260 in 1 CARTON07/31/2020
    1NDC:73862-218-116 in 1 CASE
    1NDC:73862-218-10100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2020
    Labeler - E.CIS Cosmetic Co.,Ltd (689846270)
    Registrant - E.CIS Cosmetic Co.,Ltd (689846270)
    Establishment
    NameAddressID/FEIBusiness Operations
    E.CIS Cosmetic Co.,Ltd689846270manufacture(73862-218)