Label: ESSENCE OF BEAUTY JAPANESE GARDEN ANTIBACTERIAL- 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 June 12, 2012

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

    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

    WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

  • OTHER INFORMATION

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

  • INACTIVE INGREDIENTS:

    WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, CARBOMER, GLYCERIN, FRAGRANCE (PARFUM), AMINOMETHYL PROPANOL, TOCOPHERYL ACETATE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), RED 33 (CI 17200), YELLOW 5 (CI 19140).

  • QUESTIONS OR COMMENTS?

    1-866-428-7327

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    ESSENCE OF BEAUTY  JAPANESE GARDEN ANTIBACTERIAL
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-468
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-468-0259 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/11/2012
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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