NDC 61657-0904 Surgery/trauma

Hypericum, Arnica, Symphytum Officinale, Bellis Perennis, Staphysagria

NDC Product Code 61657-0904

NDC CODE: 61657-0904

Proprietary Name: Surgery/trauma 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: Hypericum, Arnica, Symphytum Officinale, Bellis Perennis, Staphysagria 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

  • 61657 - White Manufacturing Inc. Dba Micro-west

NDC 61657-0904-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Surgery/trauma with NDC 61657-0904 is a a human over the counter drug product labeled by White Manufacturing Inc. Dba Micro-west. The generic name of Surgery/trauma is hypericum, arnica, symphytum officinale, bellis perennis, staphysagria. The product's dosage form is liquid and is administered via oral form.

Labeler Name: White Manufacturing Inc. Dba Micro-west

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Surgery/trauma 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.

  • ST. JOHN'S WORT 30 [hp_X]/30mL
  • ARNICA MONTANA FLOWER 200 [hp_X]/30mL
  • COMFREY ROOT 6 [hp_X]/30mL
  • BELLIS PERENNIS 12 [hp_X]/30mL
  • DELPHINIUM STAPHISAGRIA SEED 12 [hp_X]/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: White Manufacturing Inc. Dba Micro-west
Labeler Code: 61657
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: 07-01-2011 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 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.

Surgery/trauma Product Label Images

Surgery/trauma 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 200XBellis 12XHypericum 30XStaphysagria 12XSymphytum 6X

Purpose

FOR THE TEMPORARY RELIEF OF SWELLING, INFLAMMATION AND PAIN DUE TO TRAUMA OR SURGERY

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Indications

FOR THE TEMPORARY RELIEF OF SWELLING, INFLAMMATION AND PAIN DUE TO TRAUMA OR SURGERY

Warnings

WARNING: Stop use and call a doctor if symptoms persist or worsen.Contains alcohol: in case of accidental overdose, consult a poison control center immediately

Pregnancy

If pregnant or breast-feeding, consult a healthcare professional before use.

Directions

DIRECTIONS: Take 6 drops 4 times a day. For ages 2 to adult

Inactive Ingredients

Alcohol (20% v/v)Purified water

Manufacture

MANUFACTURED FORMICRO-WESTP.O. Box 950DOUGLAS, WY 826331-307-358-5066

* Please review the disclaimer below.