NDC 69842-097 Ear Drops

Carbamide Peroxide 6.5%

NDC Product Code 69842-097

NDC Code: 69842-097

Proprietary Name: Ear Drops What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Carbamide Peroxide 6.5% What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 69842 - Cvs Pharmacy
    • 69842-097 - Ear Drops

NDC 69842-097-45

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC 69842-097-90

Package Description: 1 CONTAINER in 1 CARTON > 15 mL in 1 CONTAINER

NDC Product Information

Ear Drops with NDC 69842-097 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Ear Drops is carbamide peroxide 6.5%. The product's dosage form is liquid and is administered via auricular (otic) form.

Labeler Name: Cvs Pharmacy

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Ear Drops Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CARBAMIDE PEROXIDE .065 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM STANNATE (UNII: NJ7C1V83KG)
  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Auricular (otic) - Administration to or by way of the ear.

Product Labeler Information

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

Labeler Name: Cvs Pharmacy
Labeler Code: 69842
FDA Application Number: part344 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-04-2019 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: 12-31-2020 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: N 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.

Ear Drops Product Label Images

Ear Drops 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

Inactive Ingredient

Citric AcidFlavorGlycerinPropylene GlycolSodium Lauroyl SarcosinateSodium StannatePurified Water

Otc - Purpose

Earwax removal aid.

Dosage & Administration

Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For External Use Only.Ask a doctor before use if you have:Ear drainage or dischargeEar pain, irritation, or rash in the earRecently had ear surgeryDizzinessAn injury or perforation (hole) of the eadrum

Otc - Active Ingredient

Carbamide Peroxide 6.5%

Indications & Usage

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

* Please review the disclaimer below.

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