Label: ADVANCE HAND SANITIZER MOISTURIZING FORMULA WITH ALOE 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 January 1, 2020

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  • Active ingredient

    Ethyl Alcohol 70.0%

  • Purpose

    Antimicrobial

  • Uses

    To help decrease bacteria on the skin. Recommended for repeat use.

  • Warnings

    For external use only.

  • WARNINGS

    Flammable. Keep away from heat and flame.

  • When using this product

    • Keep out of eyes. In case of contact, rinse eyes thoroughly with water

    • Avoid contact with broken skin

    • Do not inhale or ingest

  • Stop use and ask a doctor if

    If irritation or redness develops.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping
    • For children under 6, use only under adult supervision
    • Not recommended for infants

  • Inactive ingredients

    water, glycerin, propylene glycol,carbomer, fragrance, triethanolamine, isopropyl myristate, aloe barbadensis powder, tocopheryl acetate, FD&C Blue 1

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ADVANCE HAND SANITIZER MOISTURIZING FORMULA WITH ALOE AND VITAMIN E 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53149-1120
    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)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53149-1120-3946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    2NDC:53149-1120-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    3NDC:53149-1120-2354 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    4NDC:53149-1120-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    5NDC:53149-1120-8236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    6NDC:53149-1120-53790 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2020
    Labeler - All Pharma LLC (078572520)
    Registrant - All Pharma LLC (078572520)
    Establishment
    NameAddressID/FEIBusiness Operations
    All Pharma LLC078572520manufacture(53149-1120)
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