Swim-EAR by Fougera Pharmaceuticals Inc. SWIM-EAR solution

Swim-EAR by

Drug Labeling and Warnings

Swim-EAR by is a Otc medication manufactured, distributed, or labeled by Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz Carton

NDC: 0168-0126-91

Swim-EAR®

EAR DRYING AID

29.57 mL (1 fl oz)

INGREDIENTS AND APPEARANCE

SWIM-EAR 
swim-ear solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0126
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	950 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0126-91	1 in 1 CARTON	04/03/1970
1		29.57 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	04/03/1970

Labeler - Fougera Pharmaceuticals Inc. (043838424)