Label: ARIEL PREMIUM SUPPLY HAND SANITIZE- alcohol gel

  • 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 May 28, 2020

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  • active ingredients

    Alcohol :62% v/v. Purpose: Antiseptic

  • Antiseptic

    hand sanitizer

  • use

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

  • Warnings

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

  • Do note use

    In children less than 2 months of age. On open skin wounds

  • WHEN USING

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

  • STOP USE

    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

    keep out of reach of children. If swalloed get medical help or contact a poison control center right away

  • Direction

    Place enought 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.

  • Other information

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

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

  • Inactive ingredients

    Water Peg-40 Castor oil Carbomer Trolamine Chloroxylenol

  • PRINCIPAL DISPLAY PANEL

    74913-620

  • INGREDIENTS AND APPEARANCE
    ARIEL PREMIUM SUPPLY HAND SANITIZE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74913-620
    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
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 0.5 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 36.2 mL  in 100 mL
    CHLOROXYLENOL (UNII: 0F32U78V2Q) 0.3 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74913-620-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2020
    Labeler - SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD (546345856)
    Registrant - SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD (546345856)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD546345856manufacture(74913-620)
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