NDC 58988-1100 Oido Sana
Isopropyl Alcohol Solution Auricular (otic)

Product Information

What is NDC 58988-1100?

The NDC code 58988-1100 is assigned by the FDA to the product Oido Sana which is a human over the counter drug product labeled by Promex Llc. The generic name of Oido Sana is isopropyl alcohol. The product's dosage form is solution and is administered via auricular (otic) form. The product is distributed in a single package with assigned NDC code 58988-1100-1 1 bottle, plastic in 1 carton / 30 ml in 1 bottle, plastic. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code58988-1100
Proprietary Name 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.
Oido Sana
Non-Proprietary Name 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.
Isopropyl Alcohol
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.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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.
Promex Llc
Labeler Code58988
FDA Application Number 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.
part344
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-31-2006
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Oido Sana?


Product Packages

NDC Code 58988-1100-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC

Product Details

What are Oido Sana Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Oido Sana Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Oido Sana Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Oido Sana Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



DRUG FACTS


Otc - Purpose



Active Ingredients:Purpose
Isopropyl alcohol 95%Ear drying aid
Anhydrous glycerin 5% baseEar drying aid

Uses



dries water in the ears


Warnings



Flammable: Keep away from fire and flame

Use only in a well ventilated area; fumes may be toxic.


Ask A Doctor Before Use If You Have



  • Ear drainage or discharge
  • Pain, irritation or rash in the ear
  • Had ear surgery
  • Dizziness

Otc - Stop Use



Stop use and ask a doctor if irritation (too much burning) or pain occurs


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

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


Directions



remove safety seal from bottle, apply 4 to 5 drops in each affected ear.


Other Information



  • Recap bottle after each use
  • Keep away from heat or direct sunlight
  • Store at room temperature
  • Do not use if safety seal is damaged or missing prior to first use

Principal Display Panel - 30 Ml Bottle Carton



OIDO® SANA

Pro-Mex®

Fast Relief for

Ears

1 fl oz (30 mL)


* Please review the disclaimer below.