Label: APEX ASEPTIC INSTANT HAND SANITIZER WITH ALOE- alcohol solution

  • 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 April 14, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

     Antimicrobial

  • Use

    Hand sanitizer to help decrease bacteria on the skin. When water, soap and towel are not available. Recommended for repeated use.

  • KEEP OUT OF REACH OF CHILDREN

    Children must be supervised in use of this product.

  • warnings:

    Flamable, keep away from fire and flame.

    For external use only

    Do not apply around eyes. Do not use in ears, mouth.

    When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

    Stop use and ask a doctor if redness or irritation lasts and persists for more than 72 hours

  • DOSAGE & ADMINISTRATION

    Pump as needed into your palms and spread on both hands. Rub into skin until dry.

    Other Information: Store below 110℉ （43℃）.

  • Inactive ingredients

    Water, Aloe, Glycerin, Carbomer, Tocopheryl Acetate, Triethanolamine. 

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    APEX ASEPTIC INSTANT HAND SANITIZER WITH ALOE 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74614-008
    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
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74614-008-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/14/2020
    Labeler - TAIZHOU BENGTE FURNITURE CO.,LTD (543459923)
    Registrant - TAIZHOU BENGTE FURNITURE CO.,LTD (543459923)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAIZHOU BENGTE FURNITURE CO.,LTD543459923manufacture(74614-008)
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