Label: ADVANCED HAND SANITIZER LAVENDER- ethyl 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 March 23, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient

    Alcohol ...........62.0%

    

  • PURPOSE

    Purpose:  Antimicrobial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • 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), Yellow 5 (CI 19140).

  • INDICATIONS & USAGE

    Hand Sanitizer

  • PRINCIPAL DISPLAY PANEL

    label1

    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.
    • flamable - keep away from flames
  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER  LAVENDER
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-013
    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
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYL FRAGMENT (UNII: 0KIZ9B76US)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71611-013-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    2NDC:71611-013-0229.5 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    3NDC:71611-013-0359 mL in 1 BOTTLE; Type 0: Not a Combination Product10/18/2017
    4NDC:71611-013-04236.6 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(71611-013)
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