Label: FRISSON BY OLIVE- ethyl alcohol gel

  • 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 10, 2021

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  • Active Ingredient:

    Ethyl Alcohol 60%

  • Purpose:

    Antimicrobial

  • Use:

    When soap and water are not available. This product helps reduce bacteria on your skin.

  • Warnings:

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    on children less than 2 months of age or on open skin wounds.

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions:

    Place enough product in palm to cover hands. Rub together until dry. Supervise children under 6 years of age when using.

  • Other information:

    Store between 15o-30o C (59o-86o F). Avoid freezing and excessive heat above 40oC (104oF). May discolor certain fabrics or surfaces.

  • Inactive ingredients:

    Water (Aqua), Methyl Gluceth-20, Fragrance (Parfum), Glycereth-7 Triacetate, Glycerin, Aloe Barbadensis Leaf Juice, Hydrolyzed Jojoba Esters, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

  • Package/Label Principal Display Panel – Bottle Label

    8 oz / 236 ml
    HAND SANITIZER


    FRISSON
    by Olive


    80384-011-01 FDA, HAND SANITIZER.
    www.scentforgood.com     @scentforgood
    Manufactured by FMI for Scent for Good, New York NY 10011

    image-02

    Label

  • Package/Label Principal Display Panel – Packet Label

    0.1 oz / 3 ml
    HAND SANITIZER


    FRISSON
    by Olive


    80384-011-03 FDA, HAND SANITIZER.
    www.scentforgood.com     @scentforgood
    Manufactured by FMI for Scent for Good, New York NY 10011

    image-02

    Label

  • INGREDIENTS AND APPEARANCE
    FRISSON BY OLIVE 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80384-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERETH-7 TRIACETATE (UNII: S9W6Z48HUP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80384-011-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2021
    2NDC:80384-011-033 mL in 1 PACKET; Type 0: Not a Combination Product08/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2021
    Labeler - SCENT FOR GOOD LLC (117627345)
    Registrant - SCENT FOR GOOD LLC (117627345)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(80384-011)
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