Label: CALMING HAND SANITIZER- alcohol spray

  • NDC Code(s): 52915-074-19, 52915-074-20
  • 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 9, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Alcohol 62%

  • 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 30 seconds

  • 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, lavandula angustifolia (French lavender) oil, salvia sclarea (clary sage) oil, safflower seed oil polyglyceryl-6 esters.

  • PRINCIPAL DISPLAY PANEL - 562 mL Spray Bottle Label

    CALIF♥RNIA BABY®

    TRUSTED
    SINCE 1995

    calming

    REFILL
    SIZE

    HAND SANITIZER
    EFFECTIVE AGAINST
    99.9% GERMS & BACTERIA

    USDA Certified Biobased
    Product 100%

    MOISTURIZING • FRESH SCENT OF FRENCH LAVENDER

    BABIES + KIDS + ADULTS

    USDA
    CERTIFIED
    BIOBASED
    PRODUCT
    PRODUCT 100%

    © 2020

    NET WT 562 mL/19 fl. oz.

    PRINCIPAL DISPLAY PANEL - 562 mL Spray Bottle Label
  • INGREDIENTS AND APPEARANCE
    CALMING HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-074
    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)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-074-2059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/01/2020
    2NDC:52915-074-19562 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A02/01/2020
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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