NDC 42346-730 Frankincense And Myrrh Arthritis Pain Therapy

Hypericum Perforatum

NDC Product Code 42346-730

NDC CODE: 42346-730

Proprietary Name: Frankincense And Myrrh Arthritis Pain Therapy 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 Perforatum 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

  • 42346 - Wise Consumer Products Co.
    • 42346-730 - Frankincense And Myrrh Arthritis Pain Therapy

NDC 42346-730-85

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC Product Information

Frankincense And Myrrh Arthritis Pain Therapy with NDC 42346-730 is a a human over the counter drug product labeled by Wise Consumer Products Co.. The generic name of Frankincense And Myrrh Arthritis Pain Therapy is hypericum perforatum. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Frankincense And Myrrh Arthritis Pain Therapy 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.

  • COCONUT OIL (UNII: Q9L0O73W7L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • MENTHOL (UNII: L7T10EIP3A)
  • MYRRH OIL (UNII: H74221J5J4)
  • LEMON OIL (UNII: I9GRO824LL)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • LANOLIN (UNII: 7EV65EAW6H)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • 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.

Product Labeler Information

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

Labeler Name: Wise Consumer Products Co.
Labeler Code: 42346
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: 12-21-2021 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.

Frankincense And Myrrh Arthritis Pain Therapy Product Label Images

Frankincense And Myrrh Arthritis Pain Therapy 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

Hypericum perforatum 3X HPUS*

Purpose

Hypericum perforatum 3X HPUS*........Topical Analgesic*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

For the temporary relief of minor aches and pains.

Warnings

For external use only

Otc - Do Not Use

  • Do not useon wounds or damaged skinover large areas of the body

Otc - When Using

  • When using this productavoid contact with the eyesdo not bandage tightly

Otc - Stop Use

  • Stop use and ask a doctorif condition worsensif irritation occursif symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age: consult a doctor.

Other Information

  • Store in a cool, dry place.tamper resistant: do not use if seal under tube cap is broken or missing.claims based on traditional homeopathc practice; not accepted mediacl evidence. Not FDA evaluated.

Inactive Ingredients

Water, Caprylic/Capric Triglycerides, Emulsifying wax, Cocos Nucifera (Coconut) Oil, Butyrospermum parkii (shea) butter, Lanolin, Glycerin, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Pelargonium Graveolens (Geranium) Flower Oil, Sodium Hydroxide, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Xanthan gum, Methyl paraben, Mentha Piperita (Peppermint) Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Propylparaben, Menthol, Boswellia Carterii (Frankincense) Oil, Commiphora Myrrha (Myrrh) Oil, Citrus Limon (Lemon) Peel Oil

* Please review the disclaimer below.