NDC 60986-1040 Acusine

Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis

NDC Product Code 60986-1040

NDC CODE: 60986-1040

Proprietary Name: Acusine 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.

Non-Proprietary Name: Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis 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.

NDC Code Structure

NDC 60986-1040-5

Package Description: 20 mL in 1 BOTTLE, SPRAY

NDC 60986-1040-6

Package Description: 15 mL in 1 BOTTLE, SPRAY

NDC Product Information

Acusine with NDC 60986-1040 is a a human over the counter drug product labeled by Marco Pharma International Llc. The generic name of Acusine is hydrastis canadensis, lycopodium clavatum, ephedra vulgaris, mezereum, petroleum, pulsatilla, thuja occidentalis. The product's dosage form is spray and is administered via nasal form.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Acusine 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.


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.

  • HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • THYMOL (UNII: 3J50XA376E)

Administration Route(s)

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

  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

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

Labeler Name: Marco Pharma International Llc
Labeler Code: 60986
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: 12-24-2021 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: 12-31-2022 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.

Acusine Product Label Images

Acusine 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

Otc - Active Ingredient

Hydrastis Canadensis 4xHPUSLycopodium Clavatum 3xHPUSEphedra Vulgaris 3xHPUSMezereum 3xHPUSPetroleum 8xHPUSPulsatilla 3xHPUSThuja Occidentalis 10xHPUSThe letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States.

Otc - Purpose

For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitis, and nasal dryness.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.

Warnings

Do not spray in eyes, mouth or ears.If pregnant or breast-feeding, ask a health professional before use.
If swallowed, get medical help or contact Poison Control Center right away.

Dosage & Administration

(Read INDICATIONS & USAGE SECTION)

Inactive Ingredient

Aqua Demineralisata; Aqua Hamamelidis; Alcohol 7.7% by volume, Glycerin and Thymol.

* Please review the disclaimer below.