Label: SWIM-EAR- isopropyl alcohol solution 

  • NDC Code(s): 0168-0126-91
  • Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Drug Facts
  • Active ingredient

    Isopropyl alcohol, 95%

    Close
  • Purpose

    Ear drying aid

    Uses

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

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

    Flammable: Keep away from fire or flame.

    Close
  • 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

    Close
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz CONTAINER

    NDC 0168-0126-91

    Swim-EAR®

    EAR DRYING AID

    29.57 mL (1 fl oz)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

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

    NDC 0168-0126-91

    Swim-EAR®

    EAR DRYING AID

    29.57 mL (1 fl oz)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER

    Close
  • INGREDIENTS AND APPEARANCE
    SWIM-EAR 
    swim-ear solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0168-0126
    Route of Administration AURICULAR (OTIC) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 950 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0126-91 1 in 1 CARTON
    1 29.57 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part344 04/03/1970
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
    Close