NDC 17089-380 Guna-il 2

Aldesleukin

NDC Product Code 17089-380

NDC 17089-380-18

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

NDC Product Information

Guna-il 2 with NDC 17089-380 is a a human over the counter drug product labeled by Guna Spa. The generic name of Guna-il 2 is aldesleukin. The product's dosage form is solution/ drops and is administered via oral form.

Labeler Name: Guna Spa

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.

Guna-il 2 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.

  • ALDESLEUKIN 4 [hp_C]/30mL

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.

  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Guna Spa
Labeler Code: 17089
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 06-17-2008 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: 12-31-2021 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 - NO 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".

* Please review the disclaimer below.

Guna-il 2 Product Label Images

Guna-il 2 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 Ingredients/Purpose

INTERLEUKIN 2   4C   IMMUNE SYSTEM SUPPORT

Uses

IMMUNE SYSTEM SUPPORT

Warnings

Stop use and ask doctor if symptoms worsen or persist more than 5 days

Keep this and all medicines out of reach of children

Pregnancy

If pregnant or breast-feeding ask a doctor before use

Directions

Take 15 minutes before meals.Adults and children 12 years and older    20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.Children  between 12 years and 6 years of age    10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.Children under 6 years     5 drops twice a day in a glass of water.

Questions

Questions?: [email protected] (484) 223-3500

* Please review the disclaimer below.