Label: THYMES FRASIER FIR HAND SANITIZER- 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 April 8, 2022

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  • Active Ingredient

    Ethyl Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Use

    To help reduce bacteria on the skin

  • Warnings

    Flammable, keep away from heat and flame. For external use on the hands only. Avoid contact with eyes. If eye contact occurs, flush thoroughly with water. Avoid contact with broken skin. For Children under 6, use only under adult supervision.

    Stop use and ask a doctor if ​​skin irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek medical assistance or contact a poison control center immediately.

  • Directions

    Deposit a small amount in your palm and briskly rub hands together until dry.

  • Inactive Ingredients

    Abies Sibirica Needle Oil, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Water

  • PRINCIPAL DISPLAY PANEL

    123

  • INGREDIENTS AND APPEARANCE
    THYMES FRASIER FIR HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-339
    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
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76150-339-73251 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    2NDC:76150-339-7254 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - Bell International Laboratories, Inc (967781555)
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