Swimmer's Ear

Swimmer's Ear
SPL v1
SPL
SPL Set ID 43778b02-e90b-36b7-e063-6394a90ab62b
Route
AURICULAR (OTIC)
Published
Effective Date 2025-11-25
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 2025-11-13

Description

Isopropyl alcohol 95% in an anhydrous glycerin 5% base

Purpose

Ear drying aid


Medication Information

Purpose

Ear drying aid

Description

Isopropyl alcohol 95% in an anhydrous glycerin 5% base

Use:
  • Dries water in the ears after swimming, bathing, showering, or other water-based activities.
Section 51945-4

Warnings:

Keep away from flame or fire

Do Not Use

in the eyes

Important:

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

Directions:
  • Apply 4 to 5 drops in each affected ear.
Other Information:
  • Store between 59°F and 86°F (15°C to 30°C). Product can temporarily be exposed to temperatures ranging from 41°F to 131°F (5°C to 55°C) during transportation.
  • Recap bottle after each use
  • Keep away from heat or direct sunlight
Inactive Ingredients

Glycerin

Stop Use and Ask A Doctor If
  • Irritation (too much burning) or pain occurs
Drug Facts: Active Ingredient

Isopropyl alcohol 95% in an anhydrous glycerin 5% base

Ask A Doctor Before Use If You Have
  • Ear drainage or discharge.
  • Pain, irritation, or rash in the ear.
  • Have had ear surgery.
  • Dizziness.
Keep This and All Drugs Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Use:
  • Dries water in the ears after swimming, bathing, showering, or other water-based activities.
Section 51945-4 (51945-4)

Purpose

Ear drying aid

Warnings:

Keep away from flame or fire

Do Not Use (Do not use)

in the eyes

Important:

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

Directions:
  • Apply 4 to 5 drops in each affected ear.
Other Information:
  • Store between 59°F and 86°F (15°C to 30°C). Product can temporarily be exposed to temperatures ranging from 41°F to 131°F (5°C to 55°C) during transportation.
  • Recap bottle after each use
  • Keep away from heat or direct sunlight
Inactive Ingredients

Glycerin

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Irritation (too much burning) or pain occurs
Drug Facts: Active Ingredient

Isopropyl alcohol 95% in an anhydrous glycerin 5% base

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • Ear drainage or discharge.
  • Pain, irritation, or rash in the ear.
  • Have had ear surgery.
  • Dizziness.
Keep This and All Drugs Out of Reach of Children. (Keep this and all drugs out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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