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  5. Label Information: Swim-ear

FDA Label for Swim-ear

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. INACTIVE INGREDIENT
    12. OTHER
    13. PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 OZ CONTAINER
    14. PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 OZ CARTON

Swim-ear Product Label

The following document was submitted to the FDA by the labeler of this product Fougera Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Otc - Do Not Use



Do not use in the eyes.


Otc - Ask Doctor



Ask a doctor before use if you have

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

Otc - When Using




Otc - Stop Use



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


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



Directions
Apply 4 to 5 drops in each affected ear.


Inactive Ingredient



Inactive ingredient
Anhydrous glycerin 5% base.


Other



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)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER - swimear1

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER - swimear1


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 - swimear2

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER - swimear2


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