Label: ANTISEPTIC HAND RUB- alcohol gel

  • NDC Code(s): 39892-0412-1
  • Packager: Owens & Minor Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2023

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  • Drug Facts

  • Active ingredient

    Alcohol denat. (anhydrous) 62%

    Purpose

    Antiseptic

  • Use

    Instant hand antiseptic

  • Warnings

    Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. For external use only.

    Keep away from fire or flame. Flammable.

    Stop use and ask a doctor

    if significant irritation or sensitization occurs.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • Directions

    • Apply to clean, dry hands
    • Wet hands thoroughly with product and allow to dry
  • Other information

    • Recommended for repeated use 
    • Reduces bacteria that can potentially cause disease
  • Inactive ingredients

    Purified water, Carbomer 2020, PPG-20 methyl glucose ether, Carbomer 980, Diisopropanolamine, Fragrance (Lemon), FD&C blue No.1, FD&C yellow No.5 

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND RUB 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)  
    DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
    LEMON (UNII: 24RS0A988O)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39892-0412-11.5 mL in 1 PACKET; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/01/2019
    Labeler - Owens & Minor Distribution, Inc. (847412269)
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