Label: AURORA ANTIBACTERIAL SANITIZER SWEET LYCHEE BERRY- ethyl alcohol liquid

  • 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 13, 2015

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 65%

    PURPOSE

    ANTISEPTIC

  • USES

    TO DECREASE BACTERIA ON THE SKIN

  • WARNINGS

    • FOR EXTERNAL USE ONLY
    • FLAMMABLE
    • KEEP AWAY FROM SOURCE OF HEAT OR FIRE

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER

    STOP USE AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

  • DIRECTIONS

    APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN 6 YEARS OF AGE AND UNDER SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

  • OTHER INFORMATION

    STORE AT A TEMPERATURE BELOW 110°F (43°C)

  • INACTIVE INGREDIENTS

    WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), BENZOPHENONE-4, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, ISOPROPYL ALCOHOL, BLUE 1 (CI 42090), RED 33 (CI 17200)

  • QUESTIONS OR COMMENTS?

    1-866-695-3030

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    AURORA  ANTIBACTERIAL SANITIZER SWEET LYCHEE BERRY
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-407
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-407-0259 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/12/2015
    Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(63148-407)
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