SWIM-EAR SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]

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SWIM-EAR SOLUTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]
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NDC 0168-0126-91
Set ID b849acb5-e20b-464c-948b-8dcc51fdaf70
Category HUMAN OTC DRUG LABEL
Packager Fougera Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number PART344
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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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