Label: NIFOLA HAND SANITIZER WITH ALOE VERA AND VITAMIN E- 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 June 12, 2020

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  • ACTIVE INGREDIENT

    Active ingredient                                  Purpose

    Ethyl Alcohol                70%  V/V    ...   Antiseptic

  • PURPOSE

    • help decrease bacteria on the hands.
    • recommended for repeated use.
  • KEEP OUT OF REACH OF CHILDREN

    if swallowed, get meical help or contact a poison control center right away.

  • INDICATIONS & USAGE

    Dispense a small amount on palms. Rub lightly until dry. Do not rinse.

  • WARNINGS

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

    Avoid contact with eyes, in case of contact, rinse with water immediately.

    If irritation develops, discontinue use and consult a doctor.

    OTHER INFORMATION: store under 105℉.

  • DOSAGE & ADMINISTRATION

    Dispense a small amount on palms. Rub lightly until dry. Do not rinse.

  • INACTIVE INGREDIENT

    Water, Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    NIFOLA HAND SANITIZER WITH ALOE VERA AND VITAMIN E 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74149-022
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74149-022-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    2NDC:74149-022-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    3NDC:74149-022-0353 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    4NDC:74149-022-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    5NDC:74149-022-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Labeler - Yiwu Yangjie Daily Chemicals Co.,Ltd. (529648827)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Yangjie Daily Chemicals Co.,Ltd.529648827manufacture(74149-022)
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