NDC 43742-1413 Itch Formula

Calendula Officinalis, Apis Mellifica, Natrum Muriaticum, Urtica Urens, Histaminum Hydrochloricum, Ledum Palustre, Sulphur, Copaiva Officinalis, Cantharis, Croton Tiglium, Graphites, Mezereum, Petroleum, Rhus Venenata, Staphysagria, Antipyrinum

NDC Product Code 43742-1413

NDC CODE: 43742-1413

Proprietary Name: Itch Formula 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: Calendula Officinalis, Apis Mellifica, Natrum Muriaticum, Urtica Urens, Histaminum Hydrochloricum, Ledum Palustre, Sulphur, Copaiva Officinalis, Cantharis, Croton Tiglium, Graphites, Mezereum, Petroleum, Rhus Venenata, Staphysagria, Antipyrinum 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

  • 43742 - Deseret Biologicals, Inc.

NDC 43742-1413-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Itch Formula with NDC 43742-1413 is a a human over the counter drug product labeled by Deseret Biologicals, Inc.. The generic name of Itch Formula is calendula officinalis, apis mellifica, natrum muriaticum, urtica urens, histaminum hydrochloricum, ledum palustre, sulphur, copaiva officinalis, cantharis, croton tiglium, graphites, mezereum, petroleum, rhus venenata, staphysagria, antipyrinum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Deseret Biologicals, Inc.

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.

Itch Formula 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.

  • CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/mL
  • APIS MELLIFERA 6 [hp_X]/mL
  • SODIUM CHLORIDE 6 [hp_X]/mL
  • HISTAMINE DIHYDROCHLORIDE 6 [hp_X]/mL
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 6 [hp_X]/mL
  • SULFUR 6 [hp_X]/mL
  • COPAIFERA OFFICINALIS RESIN 8 [hp_X]/mL
  • LYTTA VESICATORIA 10 [hp_X]/mL
  • CROTON TIGLIUM SEED 12 [hp_X]/mL
  • GRAPHITE 12 [hp_X]/mL
  • DAPHNE MEZEREUM BARK 12 [hp_X]/mL
  • KEROSENE 12 [hp_X]/mL
  • TOXICODENDRON VERNIX LEAFY TWIG 12 [hp_X]/mL
  • DELPHINIUM STAPHISAGRIA SEED 12 [hp_X]/mL
  • ANTIPYRINE 16 [hp_X]/mL

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.
  • 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: Deseret Biologicals, Inc.
Labeler Code: 43742
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: 12-06-2018 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.

Itch Formula Product Label Images

Itch Formula 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:

Calendula Officinalis 3X, Apis Mellifica 6X, Natrum Muriaticum 6X, Urtica Urens 6X, Histaminum Hydrochloricum 6X, 12X, 30X, Ledum Palustre 6X, 12X, 30X, Sulphur 8X, Copaiva Officinalis 10X, Cantharis 12X, Croton Tiglium 12X, Graphites 12X, Mezereum 12X, Petroleum 12X, Rhus Venenata 12X, Staphysagria 12X, Antipyrinum 16X.

Homeopathic Indications:

For the temporary relief of symptoms related to itching, such as hives, itching at night, intolerable scratching, insect bites, poison ivy exposure, skin irritation, dry skin, and lice.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

For the temporary relief of symptoms related to itching, such as hives, itching at night, intolerable scratching, insect bites, poison ivy exposure, skin irritation, dry skin, and lice.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Warnings:

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.If pregnant or breast-feeding, ask a health professional before use.Tamper seal: "Sealed for Your Protection."Do not use if seal is broken or missing.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Directions:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

Dist. By: Deseret Biologicals, Inc.469 W. Parkland DriveSandy, UT 84070 www.desbio.com

Package Label Display:

DESBIONDC 43742-1413-1HOMEOPATHICITCHFORMULA1 FL OZ (30 ml)

* Please review the disclaimer below.