Label: LEMON MYRTLE HAND SANITIZER- alcohol spray

  • NDC Code(s): 52915-066-19, 52915-066-20
  • Packager: ORGANIC & SUSTAINABLE BEAUTY
  • 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 November 17, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Uses

    For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Discontinue use if irritation and redness develop. If condition persists for more than 72 hrs consult a doctor.

    Flammable, keep away from fire or flame.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Spray on palm, rub hands together for approximately 20 seconds. Do not rinse.

  • Other information

    Protect the product in this container from excessive heat and direct sunlight

    • Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016
  • Inactive ingredients

    Water, glycerin, safflower seed oil polyglyceryl-6 esters, backhousia citriodora (lemon myrtle) leaf extract.

  • PRINCIPAL DISPLAY PANEL - 562 mL Bottle Label

    CALIF♥RNIA BABY®

    TRUSTED
    SINCE 1995

    lemon myrtle

    REFILL
    SIZE

    HAND SANITIZER
    EFFECTIVE AGAINST MANY
    COMMON GERMS & BACTERIA

    USDA Certified Biobased
    Product 100%

    MOISTURIZING • LEMONY-LIME SCENT

    BABIES + KIDS + ADULTS

    ALLERGY
    TESTED

    © 2021

    562 mL/19 Fl. Oz.

    USDA
    CERTIFIED
    BIOBASED
    PRODUCT
    PRODUCT 100%

    PRINCIPAL DISPLAY PANEL - 562 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LEMON MYRTLE HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN)  
    BACKHOUSIA CITRIODORA LEAF OIL (UNII: 2UQQ0PI06P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-066-2059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/30/2015
    2NDC:52915-066-19562 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A10/30/2015
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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