Label: SIMPLEAF ADVANCED HAND SANITIZER MOISTURIZER AND VITAMIN E AND ALOE- 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 22, 2020

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  • ACTIVE INGREDIENT

    Active ingredient(s)                                Purpose

    Alcohol  71%       ...............                 Antiseptic

  • PURPOSE

    • Hand sanitizer to help decrease bacteria on the skin.
    • When water, soap and towel are not available.
    • Recommendd for repeated use.
  • KEEP OUT OF REACH OF CHILDREN

    Children must be supervised in use of this product.

  • INDICATIONS & USAGE

    • Wet hands thoroughly with product and allow to dry without wiping
    • adult supervision required for children under 6
    • Not recommended for infants.
  • WARNINGS

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

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

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

    Stop using, consult doctor if redness or irritation develop and persist for more than 72 hours.

  • DOSAGE & ADMINISTRATION

    Other information:

    • Do not Store above 105℉
    • might be harmful to wood and plastic
  • INACTIVE INGREDIENT

    Water, Triethanolamine, Glycerin, Propylene glycol, Aloe Barbadensis gel, carbomer, vitamin E

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    SIMPLEAF ADVANCED HAND SANITIZER MOISTURIZER AND VITAMIN E AND ALOE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75780-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75780-012-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/22/2020
    Labeler - NINGBO MEINEKE Biotech Technology Co., Ltd. (413126185)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO MEINEKE Biotech Technology Co., Ltd.413126185manufacture(75780-012)
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