NDC 59985-322 Remedi Health Solutions Antihistamine Action

Apis Mellifica, Ledum Palustre, Vespa Crabro, Histamine, Cresolum

NDC Product Code 59985-322

NDC CODE: 59985-322

Proprietary Name: Remedi Health Solutions Antihistamine Action 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: Apis Mellifica, Ledum Palustre, Vespa Crabro, Histamine, Cresolum 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

  • 59985 - Chc Montana

NDC 59985-322-32

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

NDC Product Information

Remedi Health Solutions Antihistamine Action with NDC 59985-322 is a a human prescription drug product labeled by Chc Montana. The generic name of Remedi Health Solutions Antihistamine Action is apis mellifica, ledum palustre, vespa crabro, histamine, cresolum. The product's dosage form is spray and is administered via oral; topical form.

Labeler Name: Chc Montana

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

Product Type: Human Prescription 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.

Remedi Health Solutions Antihistamine Action 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.

  • APIS MELLIFERA 30 [hp_C]/30mL
  • RHODODENDRON AUREUM LEAF 30 [hp_C]/30mL
  • VESPA CRABRO 30 [hp_C]/30mL
  • HISTAMINE 30 [hp_C]/30mL
  • CRESOL 30 [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.

  • WATER (UNII: 059QF0KO0R)
  • 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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Standardized Insect Venom Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Bee Venoms - [CS]

Product Labeler Information

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

Labeler Name: Chc Montana
Labeler Code: 59985
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: 01-01-2019 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: 12-31-2020 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.

Remedi Health Solutions Antihistamine Action Product Label Images

Remedi Health Solutions Antihistamine Action 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

Hpus Active Ingredients

APIS MELLIFICA 30cLEDUM PALUSTRE 30cVESPA CRABRO 30cHISTAMINE 30cCRESOLUM 30c

Purpose

APIS MELLIFICA 30c ..................Red, hot, puffy, swollen, stingingLEDUM PALUSTRE 30c.....................Bites, sticking pain, puncturesVESPA CRABRO 30c....................................Intense itching of skinHISTAMINE 30c ......................Multiple common allergy symptomsCRESOLUM 30c..................Painful ulcerations, blistering

Uses

For red, hot, stinging, intense, itching allergy symptoms including bites, punctures, and hives.

Warnings

Do not use if seal is broken or missing.As with any drug, ask a doctor before use if pregnant or breastfeeding. This formula is highly diluted homeopathic and is generally safe for all ages. Call your provider if symptoms worsen after 7 days. Homeopathic Remedies have no known drug interactions.

Otc - Keep Out Of Reach Of Children

Keep this and all medication out of the reach of children. In case of accidental overdose contact a medical professional or Poison Control Center immediately. The active homeopathic ingredients are diluted beyond 1 part per million.

Directions

Repeat 1 oral spray or one topical spray three times in a row, separated five minutes apart. May be repeated three additional times or if needed for pain, itch and swelling up to 5x’s daily for up to 7 days.

Inactive Ingredients:

Alcohol Min. 20% and Water

* Please review the disclaimer below.