NDC 0927-0086 Dri-ear Drops

Isopropyl Alcohol

NDC Product Code 0927-0086

NDC 0927-0086-31

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Dri-ear Drops with NDC 0927-0086 is a a human over the counter drug product labeled by Pfeiffer Pharmaceuticals, Inc. The generic name of Dri-ear Drops is isopropyl alcohol. The product's dosage form is liquid and is administered via auricular (otic) form.

Labeler Name: Pfeiffer Pharmaceuticals, Inc

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.

Dri-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.

  • ISOPROPYL ALCOHOL .76 g/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)

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: Pfeiffer Pharmaceuticals, Inc
Labeler Code: 0927
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: 09-30-1996 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.

Dri-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

Other

Drug Facts

Flammable: keep away from fire or flame

Active Ingredient

Isopropyl Alcohol 95%

Inactive Ingredient

Glycerin 5%

Purpose

Ear drying aid
Ear drying aid

Uses

  • Dries water in the ears. Relieves water clogged ears after
  • Swimming
  • Showering
  • Bathing
  • Washing the hair

Otc - Do Not Use

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
  • Had ear surgery
  • Dizziness

Stop Use And Ask A Doctor If

  • Irritation (too much burning) or pain occurs

Keep Out Of Reach Of Children.

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

Directions

  • Apply 4 to 5 drops in each affected ear.

Other Information

Store at 15°-30°C (59°-86° F). Keep bottle tightly closed when not in use.

* Please review the disclaimer below.