Label: HUMCO EAR DROPS FOR SWIMMERS- isopropyl alcohol liquid

  • NDC Code(s): 0395-0098-91
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 16, 2022

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  • SPL UNCLASSIFIED SECTION

    HUMCO Ear Drops for Swimmers

    Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 95% in anhydrous glycerin

  • Purpose

    Ear drying aid

  • Use

    Dries water in the ears.

  • Warnings

    Flammable: Keep away from fire and flame.

    Do not use

    in the eyes.

    Ask a doctor before use if you have

    Ear drainage or discharge.

    Pain, irritation, or rash in the ear.

    Have had ear surgery.

    Dizziness.

    Stop use and ask doctor if

    Irritation (too much burning) or pain occurs.

    If pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

    • In case of accidental ingestion, seek professional assistant or contact a Poison Control Center immediately. 
  • Directions

    Apply 4 to 5 drops in each affected ear.

  • Other information

    Store at room temperature.

  • Inactive Ingredient

    Glycerin

  • Principal Display Panel

    capture

  • INGREDIENTS AND APPEARANCE
    HUMCO EAR DROPS FOR SWIMMERS 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0098
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL950 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-0098-911 in 1 CARTON01/01/2008
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34401/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-0098) , analysis(0395-0098) , pack(0395-0098) , label(0395-0098)
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