Label: AMORAY- ethyl alcohol aerosol, spray

  • 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 January 5, 2021

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  • Purpose

    Sanitizer Spray

  • Active Ingredients..................Purpose

    Ethyl Alcohol 70%.................................................................. Purpose: Antiseptic

  • Uses

    • Hand sanitizer to help reduce germs in the skin that can potentially cause diseases.
    • Recommended for repeated use.
  • Warnings

    For external use only.

    • Flammable: Keep away from fire or flame.

    Contents under pressure.

    • Do not puncture or incinerate.

    Do not store at temperatures above 120°F(48°C).

    When using this product

    • Keep our of eyes. In case of eye contact, flush eyes with water.
    • Avoid contact with broken skin.

    Stop use and ask a doctor

    Stop use and ask a doctor if irritation or redness develops, or if condition persist for more than 72 hours.

    Keep out of reach of children

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

  • Directions

    • Wet hands thoroughly with product.
    • Rub hands together for 15 seconds, pay attention between fingers, fingernails and cuticles.
    • Allow to dry without wiping.
  • Inactive Ingredients

    Water, Butane, Isobutane, Propane, Glycerin, PEG-40 Hydrogenated Castor Oil, Panthenol, Aloe Barbadensis Leaf Juice (Aloe Vera), Tocopheryl Acetate (Vitamin E)

  • Questions or comments?

    Questions or comments? 1-877-879-6999

  • Package Label

    75 ML, NDC:75822-027-03

    label

  • INGREDIENTS AND APPEARANCE
    AMORAY 
    ethyl alcohol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75822-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL  in 100 mL
    ISOBUTANE (UNII: BXR49TP611) 5 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
    BUTANE (UNII: 6LV4FOR43R) 9.1 mL  in 100 mL
    PROPANE (UNII: T75W9911L6) 5.1 mL  in 100 mL
    PANTHENOL (UNII: WV9CM0O67Z) 0.1 mL  in 100 mL
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 10.1 mL  in 100 mL
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.3 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75822-027-0375 mL in 1 CAN; Type 0: Not a Combination Product04/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/26/2020
    Labeler - KOZMO KIMYA SANAYI VE DIS TICARET LIMITED SIRKETI (535362693)
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