Label: SPATHERAPY ANTIBACTERIAL FRENCH LAVENDER- alcohol gel

  • NDC Code(s): 73025-169-00
  • Packager: Shalom International Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Drug Facts

  • Active ingredient

    Alcohol Denat. 62%

    Purpose

    Antibacterial

  • Use

    To decrease bacteria on the skin and clean hands. Recommended for repeated use.

  • Warnings

    For external use only.

    Flammable, keep away from flames.

    When using this product

    do not get into eye. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    irritation or redness develop or persists for more than 72 hours

    Keep out of reach of children.

  • Directions

    Apply to hands until thoroughly wet. Rub vigorously until dry.

  • Inactive ingredients

    Water, Fragrance (Parfum), Carbomer, Aminomethyl Propanol, D&C Red No.33, FD&C Blue No.1.

  • Package Labeling:

    Label10

  • INGREDIENTS AND APPEARANCE
    SPATHERAPY ANTIBACTERIAL FRENCH LAVENDER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73025-169
    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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73025-169-0030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/15/2021
    Labeler - Shalom International Corp (001384825)
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