SPL v3
SPL
SPL Set ID 5f0bb412-577e-3155-e053-2a91aa0a7f53
Route
AURICULAR (OTIC)
Published
Effective Date 2017-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.95 g)
Inactive Ingredients
Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-02-01

Description

Active Ingredients Isopropyl alcohol, 95%


Medication Information

Warnings and Precautions

Warnings

Flammable:Keep away from fire or flame.

Do not use in the eyes.

Indications and Usage

Uses

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

  • swimming
  • showering
  • bathing
  • washing the hair
Dosage and Administration

Directions

Apply 4 to 5 drops in each affected ear.

Description

Active Ingredients Isopropyl alcohol, 95%

Section 50565-1

Keep our of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50569-3

Ask a doctor before use if you have

  • ear drainage or dischage
  • pain, irritiaon, or rash in ear
  • had ear surgery
  • dizziness
Section 51945-4

Section 53413-1

Questions or comments?

1-800-635-3696

Section 55105-1

Purpose

Ear Drying aid in an Anhydrous glycerin base, 5%

Section 55106-9

Active Ingredients

Isopropyl alcohol, 95%


Structured Label Content

Indications and Usage (34067-9)

Uses

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

  • swimming
  • showering
  • bathing
  • washing the hair
Dosage and Administration (34068-7)

Directions

Apply 4 to 5 drops in each affected ear.

Warnings and Precautions (34071-1)

Warnings

Flammable:Keep away from fire or flame.

Do not use in the eyes.

Section 50565-1 (50565-1)

Keep our 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 aks 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 dischage
  • pain, irritiaon, or rash in ear
  • had ear surgery
  • dizziness
Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-635-3696

Section 55105-1 (55105-1)

Purpose

Ear Drying aid in an Anhydrous glycerin base, 5%

Section 55106-9 (55106-9)

Active Ingredients

Isopropyl alcohol, 95%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)