NDC 42346-725 Frankincense And Myrrh Arthritis Pain Relief

Aconitum Napellus, Bryonia Alba, Hypericum Perforatum

NDC Product Code 42346-725

NDC CODE: 42346-725

Proprietary Name: Frankincense And Myrrh Arthritis Pain Relief 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: Aconitum Napellus, Bryonia Alba, 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
    • 42346-725 - Frankincense And Myrrh Arthritis Pain Relief

NDC 42346-725-59

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 59 mL in 1 BOTTLE, DROPPER

NDC Product Information

Frankincense And Myrrh Arthritis Pain Relief with NDC 42346-725 is a a human over the counter drug product labeled by Wise Consumer Products. The generic name of Frankincense And Myrrh Arthritis Pain Relief is aconitum napellus, bryonia alba, hypericum perforatum. The product's dosage form is oil and is administered via topical form.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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 Relief 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.

  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • LEMON OIL (UNII: I9GRO824LL)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • CINNAMON LEAF OIL (UNII: S92U8SQ71V)
  • MYRRH OIL (UNII: H74221J5J4)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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
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 Relief 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

Aconitum napellus 3X HPUS*Bryonia alba 3X HPUS*Hypericum perforatum 3X HPUS*

Purpose

Aconitum napellus 3X HPUS*.......................Minor Pain RelieverBryonia alba 3X HPUS*................................Anti-inflammatoryHypericum perforatum 3X HPUS*................Topical Analgesic*The letters "HPUS" indicate that the components in this product are officially monographed in the 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 doctor ifcondition worsensirritation occurssymptoms 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 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 10-30 drops into palm or hand and massage into affected areas
  • Massage oil in hand to coat painful areascan be used up to 4 times dailychildren under 12 years of age: consult a physician

Other Information

  • Store in a cool, dry placetamper resistant: do not use if seal around bottle neck is broken or missingkeep carton, it contains important informationclaims based on traditional homeopathic practice; not accepted medical evidence. Not FDA evaluated.

Inactive Ingredients

Boswellia Carterii (Frankincense) Oil, Cinnamomum Zeylanicum (Cinnamon) Leaf Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Commiphora Myrrha (Myrrh) Oil, Eucalyptus Globulus Leaf Oil, Helianthus Annuus (Sunflower) Seed Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Mentha Piperita (Peppermint) Oil, Pelargonium Graveolens (Geranium) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Tocopherol

* Please review the disclaimer below.