Topcare Swimmers Ear Drops Liquid
FDA Label NDC 36800-064

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates for the product Topcare Swimmers Ear Drops (NDC 36800-064). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, ask a doctor before use if you have, stop use and ask doctor if, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Isopropyl Alcohol 95% in anhydrous glycerin

Purpose

Ear drying aid

Use

Dries water in the ears.

Warnings

Flammable: Keep away from fire and flame.

Do Not Use

in the eyes.

Ask A Doctor Before Use If You Have

Ear drainage or discharge.

Pain, irritation, or rash in the ear.

Have had ear surgery.

Dizziness.

Stop Use And Ask Doctor If

Irritation (too much burning) or pain occurs.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

  • In case of accidental ingestion, seek professional assistant or contact a Poison Control Center immediately. 

Directions

Apply 5 to 5 drops in each affected ear..

Other Information

Store at room temperature.

Inactive Ingredient

Glycerin

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