Swim-EAR ® EAR DRYING AID

Swim-EAR ® EAR DRYING AID

Drug Labeling and Warnings

Drug Details

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SWIM-EAR- swim-ear 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 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 CARTON
129.57 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34404/03/1970
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 11/2013
 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.


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