NDC 0023-6934 Ocumend Healing Gels

Arnica Montana And Ledum Palustre Twig

NDC Product Code 0023-6934

NDC 0023-6934-13

Package Description: 13 POUCH in 1 CARTON > 2 PATCH in 1 POUCH (0023-6934-02)

NDC Product Information

Ocumend Healing Gels with NDC 0023-6934 is a a human over the counter drug product labeled by Allergan, Inc.. The generic name of Ocumend Healing Gels is arnica montana and ledum palustre twig. The product's dosage form is patch and is administered via topical form.

Labeler Name: Allergan, Inc.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Ocumend Healing Gels 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.

  • ARNICA MONTANA 50 [hp_X]/1
  • LEDUM PALUSTRE TWIG 50 [hp_X]/1

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.

  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • METHYL DIETHANOLAMINE (UNII: 3IG3K131QJ)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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: Allergan, Inc.
Labeler Code: 0023
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: 09-01-2020 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 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.

Ocumend Healing Gels 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

Arnica Montana 50M 50% HPUS
     
Ledum Palustre 50M 50% HPUS

Homeopathic Purpose

Arnica Montana 50M HPUS: Bruising
     
Ledum Palustre 50M HPUS: Black Eye

Uses

For the reduction of bruising, swelling, and pain.

Warnings

For external use only

Do Not Use

In the eyes, over open wounds, or if you have unexpected bleeding

Stop Use And Ask A Doctor If

Condition worsens.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Use as directed by a physician. Place healing gels on intact skin and replace as needed.

Other Information

Store at room temperature.

Inactive Ingredients

Acrylates/Acrylamide Co-polymer, Hydroxyethyl Cellulose, Methyldiethanolamine, Water

Questions?

Call: 1 (800) 678-1605

Description:

The letters ‘HPUS’ indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
     
Do not use if peel pouches are open.

* Please review the disclaimer below.