Label: SAFERENCE SANITIZER- lavandula angustifolia oil liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 24, 2020

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  • ACTIVE INGREDIENT

    lavender oil

  • PURPOSE

    see attached Drug Facts label

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • WARNINGS

    see attached Drug Facts label

  • DOSAGE & ADMINISTRATION

    for external use only

  • INACTIVE INGREDIENT

    silia, water, propanediol, olive oil, etc (see attached Drug Facts label)

  • INDICATIONS & USAGE

    pour small amount into hands, spread evenly and rub into the skin

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SAFERENCE SANITIZER 
    lavandula angustifolia oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75693-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8) (LAVENDER OIL - UNII:ZBP1YXW0H8) LAVENDER OIL0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75693-0001-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    2NDC:75693-0001-250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2020
    Labeler - MAY MEDIC CO LTD (695893304)
    Registrant - MAY MEDIC CO LTD (695893304)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAY MEDIC CO LTD695893304manufacture(75693-0001)