NDC 37205-457 Earwax Removal Aid

NDC Product Code 37205-457

NDC 37205-457-05

Package Description: 15 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Earwax Removal Aid with NDC 37205-457 is a product labeled by Cardinal Health. The generic name of Earwax Removal Aid is . The product's dosage form is and is administered via form.

Labeler Name: Cardinal Health

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cardinal Health
Labeler Code: 37205
Start Marketing Date: 02-06-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Earwax Removal Aid Product Label Images

Earwax Removal Aid Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient(S)

Carbamide Peroxide 6.5%

Purpose

Earwax Removal Aid

Use(S)

For occasional use to soften, loosen and remove excessive earwax.

Warning

For External Use Only

Do Not Use

  • In the eyefor more than 4 days

Ask A Doctor Before Use If You Have

  • Ear drainage or dischargepain, irritation or rash in the earhad ear surgeryan injury or perforation (hole) in the ear drum

Stop Use And Ask A Doctor If

Stop use and ask a doctor if excessive earwax remains after use

Keep Out Of Reach Of Children

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

Directions

FOR USE IN THE EAR ONLYAdults and children 12 years of age: tilt head sideways and place 5 to 10 drops into ear.  Tip of applicator should not enter ear canal.  Keep drops in ear for several minutes by keeping head tilted, or placing cotton in the ear.  Use twice daily for up to 4 days, if needed, or as directed by a doctor.  Any wax remaining after treatment my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age, consult a doctor.

Other Information

Do not use if imprinted seal on cap is broken or missing.

Storage

  • Store at controlled room temperature 15 to 30C (59 to 86F)KEEP IN A DRY PLACE

Inactive Ingredients

Anhydrous Glycerin

* Please review the disclaimer below.