Label: ADVANCED HAND SANITIZER LAVENDER- ethyl alcohol gel

  • NDC Code(s): 71611-013-01, 71611-013-02, 71611-013-03, 71611-013-04
  • 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 October 19, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredient

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

    

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  • PURPOSE

    Purpose:  Antimicrobial

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • DOSAGE & ADMINISTRATION

    Directions

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

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  • INDICATIONS & USAGE

    Hand Sanitizer

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  • 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
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  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER  LAVENDER
    ethyl alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71611-013
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 g  in 53 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71611-013-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2017
    2 NDC:71611-013-02 29.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2017
    3 NDC:71611-013-03 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2017
    4 NDC:71611-013-04 236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 10/18/2017
    Labeler - Click Products LLC (080766174)
    Establishment
    Name Address ID/FEI Business Operations
    Glint Cosmetic Private Limited 675910492 manufacture(71611-013)
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