swim-ear ®

swim-ear ®
SPL v4
SPL
SPL Set ID b849acb5-e20b-464c-948b-8dcc51fdaf70
Route
auricular (otic)
Published
Effective Date 2019-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (950 mg)
Inactive Ingredients
glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1970-04-03

Purpose

Ear drying aid

Description

Isopropyl alcohol, 95%


Medication Information

Warnings

Flammable: Keep away from fire or flame.

Uses

Dries water in the ears and relieves water-clogged ears after:

  • swimming
  • showering
  • bathing
  • washing the hair.
Purpose

Ear drying aid

Dosage and Administration

Directions

Apply 4 to 5 drops in each affected ear.

Description

Isopropyl alcohol, 95%

Section 42229-5
  •  
    E. FOUGERA & CO.

    A division of

    Fougera Pharmaceuticals Inc.

    Melville, New York 11747

    IP4808C

    R10/12

    #8
Section 50565-1
  •  
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  •  
    Stop use and ask a doctor if irritation (too much burning) or pain occurs.
Section 50569-3

Ask a doctor before use if you have

  • ear drainage or discharge
  • pain, irritation or rash in ear
  • had ear surgery
  • dizziness
Section 50570-1

Do not use in the eyes.

Section 51727-6

Inactive ingredient

Anhydrous glycerin 5% base.

Active Ingredient

Isopropyl alcohol, 95%

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 Oz Container

NDC 0168-0126-91

Swim-EAR®

EAR DRYING AID

29.57 mL (1 fl oz)


Structured Label Content

Warnings

Flammable: Keep away from fire or flame.

Uses

Dries water in the ears and relieves water-clogged ears after:

  • swimming
  • showering
  • bathing
  • washing the hair.
Purpose

Ear drying aid

Dosage and Administration (34068-7)

Directions

Apply 4 to 5 drops in each affected ear.

Section 42229-5 (42229-5)
  •  
    E. FOUGERA & CO.

    A division of

    Fougera Pharmaceuticals Inc.

    Melville, New York 11747

    IP4808C

    R10/12

    #8
Section 50565-1 (50565-1)
  •  
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  •  
    Stop use and ask a doctor if irritation (too much burning) or pain occurs.
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • ear drainage or discharge
  • pain, irritation or rash in ear
  • had ear surgery
  • dizziness
Section 50570-1 (50570-1)

Do not use in the eyes.

Section 51727-6 (51727-6)

Inactive ingredient

Anhydrous glycerin 5% base.

Active Ingredient (Active ingredient)

Isopropyl alcohol, 95%

Package Label – Principal Display Panel – 1 Oz Carton (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 Oz Container (PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz CONTAINER)

NDC 0168-0126-91

Swim-EAR®

EAR DRYING AID

29.57 mL (1 fl oz)


Advanced Ingredient Data


Raw Label Data

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