Label: ADVANCED HAND SANITIZER VITAMIN E- ethyl alcohol gel

  • NDC Code(s): 71611-011-01, 71611-011-02, 71611-011-03, 71611-011-04, view more
    71611-011-05, 71611-011-06, 71611-011-07, 71611-011-08, 71611-011-09, 71611-011-10, 71611-011-11, 71611-011-12, 71611-011-13, 71611-011-14, 71611-011-15, 71611-011-16, 71611-011-17
  • Packager: Click Products LLC
  • 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 9, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol...........62%

  • PURPOSE

    Antimicrobial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    Warnings

    • for external use only-hands.
    • keep out of eyes. avoid contact with broken skin.
    • stop use and ask a Doctor if irritation or redness develops.
    • do not inhale or ingest. if swallowed, get medical help or contact a poison control center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • Rub a dime sized drop into hands.
    • For children under 6 use under adult supervision.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    water (aqua/eau), glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, hydrogenated castor oil, fragrance (parfum).

    May Contain

    Red 40 (CI 16035), Red 33 (CI 17200), Blue 1 (CI 42090)

  • INDICATIONS & USAGE

    Hand Sanitizer

  • PRINCIPAL DISPLAY PANEL

    label1

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER  VITAMIN E
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 53 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYL FRAGMENT (UNII: 0KIZ9B76US)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71611-011-0153 mL in 1 BOTTLE; Type 0: Not a Combination Product10/19/2017
    2NDC:71611-011-0229.5 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    3NDC:71611-011-04236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    4NDC:71611-011-0359 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    5NDC:71611-011-0580 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    6NDC:71611-011-06100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    7NDC:71611-011-07222 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    8NDC:71611-011-08350 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    9NDC:71611-011-09400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    10NDC:71611-011-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    11NDC:71611-011-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    12NDC:71611-011-122000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    13NDC:71611-011-1353 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    14NDC:71611-011-1459 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    15NDC:71611-011-1590 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    16NDC:71611-011-16300 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    17NDC:71611-011-171800 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/18/2017
    Labeler - Click Products LLC (080766174)
    Establishment
    NameAddressID/FEIBusiness Operations
    PRIYAL COSMETICS675482356manufacture(71611-011)