Label: EPU PREMIUM MANDARIN HAND SANITIZER 70 500ML- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 8, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

    Active Ingredient(s)

  • Purpose

    Antiseptic, Hand Sanitizer

    Purpose

  • Use

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

    Use

  • Warnings

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

    Warnings

  • 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℃ to 30℃ (59℉ to 86℉)
    • Avoid freezing and excessive heat above 40℃ (104℉)

    Other information

  • Inactive ingredients

    Water, Glycerin, Fragrance, Carbomer, Aminomethyl Propanol, Mentha Arvensis Leaf Oil, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate

    Inactive ingredients

  • Package Label - Principal Display Panel

    E-Pu

    Premium Mandarin

    Hand Sanitizer

    70% Ethyl Alcohol as recommended

    Help reduce bacteria on the skin

    • Natural* Mandarin Zest and Herbal Oils Blend
    • Complies with ISO 9235**
    • Glycerin, Sodium Hyaluronate & Aloe Vera to replace Moisture

    500mL (16.9 fl.oz.)

    Package Label

  • INGREDIENTS AND APPEARANCE
    EPU PREMIUM MANDARIN HAND SANITIZER 70 500ML 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73862-209
    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
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73862-209-034 in 1 PACKAGE05/29/2020
    1NDC:73862-209-0224 in 1 CASE
    1NDC:73862-209-01500 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 finalpart333A05/29/2020
    Labeler - E.CIS Cosmetic Co.,Ltd (689846270)
    Establishment
    NameAddressID/FEIBusiness Operations
    E.CIS Cosmetic Co.,Ltd689846270manufacture(73862-209)
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