Label: SWIM-EAR solution

  • NDC Code(s): 0168-0126-91
  • Packager: Fougera Pharmaceuticals 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 29, 2021

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  • Drug Facts

  • Active ingredient

    Isopropyl alcohol, 95%

  • Purpose

    Ear drying aid

    Uses

    Dries water in the ears and relieves water-clogged ears after:

    •
    swimming
    •
    showering
    •
    bathing
    •
    washing the hair.
  • Warnings

    Flammable: Keep away from fire or flame.

  • SPL UNCLASSIFIED SECTION

    Do not use in the eyes.

    Ask a doctor before use if you have

    •
    ear drainage or discharge
    •
    pain, irritation or rash in ear
    •
    had ear surgery
    •
    dizziness

     
    Stop use and ask a doctor if irritation (too much burning) or pain occurs.

     
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Directions
    Apply 4 to 5 drops in each affected ear.

    Inactive ingredient
    Anhydrous glycerin 5% base.

     
    E. FOUGERA & CO.
    A division of
    Fougera Pharmaceuticals Inc.
    Melville, New York 11747
    IP4808C
    R10/12
    #8
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz CONTAINER

    NDC 0168-0126-91

    Swim-EAR®

    EAR DRYING AID

    29.57 mL (1 fl oz)

    Swimear1
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz Carton

    NDC 0168-0126-91

    Swim-EAR®

    EAR DRYING AID

    29.57 mL (1 fl oz)

    Swimear2
  • INGREDIENTS AND APPEARANCE
    SWIM-EAR 
    swim-ear solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0126
    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:0168-0126-911 in 1 CARTON04/03/1970
    129.57 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34404/03/1970
    Labeler - Fougera Pharmaceuticals Inc. (043838424)
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