NDC 49035-862 Ear Wax Removal Drops Equate

Carbamide Peroxide - 6.5%

NDC Product Code 49035-862

NDC 49035-862-01

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

NDC 49035-862-02

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

NDC Product Information

Ear Wax Removal Drops Equate with NDC 49035-862 is a a human over the counter drug product labeled by Walmart Stores Inc. The generic name of Ear Wax Removal Drops Equate is carbamide peroxide - 6.5%. The product's dosage form is solution/ drops and is administered via topical form.

Labeler Name: Walmart Stores Inc

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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 Wax Removal Drops Equate 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 65 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TARTARIC ACID (UNII: W4888I119H)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Walmart Stores Inc
Labeler Code: 49035
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: 03-01-2019 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: 12-31-2019 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 Wax Removal Drops Equate 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

Carbamide Peroxide, 6.5%

Purpose

Earwax removal aid

Uses

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

Warnings

  • Ask a Doctor before use if you have eardrainage, discharge, ear pain,irritationrash in the ear,or are dizzyinjury or perforation (hole) of the ear drumRecently had ear surgery

Stop Use And Ask A Doctor If

  • You need to use for more than 4 daysexecessive ear wax remain after use of this product

When Using This Product

  • Do not use for more than four daysavoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctorif excessive earwax remains after the use of this product, consult a doctor

Keep Out Of The Reach Of Children

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

Directions For Use In The Ear Only

  • Adults and children over 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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.Children under 12 years:  consult a doctor.

Other Information

  • Protect from heat and direct sunlight product foams on contact with ear wax due ot releae of oxygen, there may be associated crackingKeep cap on bottle when not in use.Lot No. and EXP date:  see label, bottom container or box.

Inactive Ingredients

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

* Please review the disclaimer below.

Previous Code
49035-861
Next Code
49035-863