Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 71513-220-00
  • Packager: Broder Bros Prime Line
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Alcohol 62%

    Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

    Flammable, keep away from fire and flame

    Does not contain

    grain alcohol;do not drink. If taken internally serious gastric disturbances will result.

    When using this product

    • Avoid the eyes and mucous membranes
    • In the case of eyes or mucous membranes contact, rinse area thoroughly with water
    • In case of deep or punture wounds or serious burns, consult physician.
    • If redness,irritation,swelling, or pain persists or increases or if infection occurs discontinue use and consult physician.

    Keep out of reach of children

    If swallowed,contact a doctor or Poison Control Center immediately

  • Directions

    • Rub dime sized amount between hands until dry.
    • Supervise children in the use of this product.
    • In the case of eye contact, rinse eyes thoroughly with water.
  • Other information

    • Store below 105 F.
    • May discolor some fabrics.
  • Inactive Ingredients

    Aminomethyl Propanol, Carbomer, Water.

  • Questions?

    1-800-873-7746 M-F 8am-5pm EST

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71513-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71513-220-0050 mL in 1 BOTTLE; Type 0: Not a Combination Product06/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/07/2020
    Labeler - Broder Bros Prime Line (107044246)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bath Concept Cosmetics (Dongguan) Co., Ltd529623933manufacture(71513-220)
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