NDC 53329-032 62% Ethyl Alcohol Antiseptic Nasal

Ethyl Alcohol

NDC Product Code 53329-032

NDC 53329-032-78

Package Description: 6 mL in 1 PACKET

NDC Product Information

62% Ethyl Alcohol Antiseptic Nasal with NDC 53329-032 is a a human over the counter drug product labeled by Medline Industries, Inc.. The generic name of 62% Ethyl Alcohol Antiseptic Nasal is ethyl alcohol. The product's dosage form is swab and is administered via topical form.

Labeler Name: Medline Industries, Inc.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

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.

62% Ethyl Alcohol Antiseptic Nasal 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.

  • ALCOHOL 62 mL/100mL

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.

  • GLYCERYL LAURATE (UNII: Y98611C087)
  • MENTHOL (UNII: L7T10EIP3A)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • CASTOR OIL (UNII: D5340Y2I9G)

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: Medline Industries, Inc.
Labeler Code: 53329
FDA Application Number: part333A 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-10-2019 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.

62% Ethyl Alcohol Antiseptic Nasal Product Label Images

62% Ethyl Alcohol Antiseptic Nasal 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

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

 antiseptic skin preparation

 helps reduce bacteria that can

cause skin infections

Warnings

 for external use only flammable, keep away from open flame

Do Not Use

 in the eyes on children under 2 years of age unless directed by a doctor

Ask A Doctor Before Use If Injuries Are

 deep or puncture wounds

 serious burns

Stop And Ask A Doctor If

 redness, irritation, swelling or pain persists

or increases

 infection occurs

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center

immediately.

Storage And Handling

Avoid excessive heat. Store at room temperature.

Directions

NASAL APPLICATION:1. Use a tissue to clean the inside of both nostrils, including the inside tip of nostril. Discard.2. Insert right swab comfortably into right nostril and rotate for 30 seconds, covering all surfaces. Discard swabstick.3. Use left swab, repeat step 2 with left nostril.4. Do not blow nose. If solution drips, gently wipe with a tissue.

Other Information

- not made with natural rubber latex- for hospital or professional use only

Inactive Ingredients

Ascorbyl Palmitate, Benzyl Alcohol, BHT,

Ricinus Communis (Castor) Seed Oil,

Glyceryl Laurate, Isopropyl Alcohol,

Menthol, Natural Fragrance,

Polyaminopropyl Biguanide,

Purified Water

Other

Protect From Freezing,

Do not store above 105°F.

Temperature limits:

25°C-40°C

* Please review the disclaimer below.