SWIM-EAR- isopropyl alcohol solution 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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.

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Swim-EAR ®
EAR DRYING AID

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.

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 – 1/2 Oz CONTAINER

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

SWIM-EAR 
swim-ear solution
Product Information
Product Type HUMAN OTC DRUG 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 (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
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)

Revised: 11/2013
Document Id: 62aa773d-b562-488f-a5a3-bc42c64ecf6f
Set id: b849acb5-e20b-464c-948b-8dcc51fdaf70
Version: 1
Effective Time: 20131115
 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.