NDC 70631-057 Thieves Essential Oil-infused Chest Rub

Camphor (natural)

NDC Product Code 70631-057

NDC 70631-057-40

Package Description: 50 g in 1 TUBE

NDC Product Information

Thieves Essential Oil-infused Chest Rub with NDC 70631-057 is a a human over the counter drug product labeled by Young Living Essential Oils. The generic name of Thieves Essential Oil-infused Chest Rub is camphor (natural). The product's dosage form is ointment and is administered via topical form.

Labeler Name: Young Living Essential Oils

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Thieves Essential Oil-infused Chest Rub 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.

  • MENTHOL .028 g/g
  • EUCALYPTUS OIL .013 g/g
  • CAMPHOR (NATURAL) .053 g/g

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.

  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • .BETA.-SITOSTEROL (UNII: S347WMO6M4)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • GLYCERYL LINOLENATE (UNII: SGB6X4G86K)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • SQUALANE (UNII: GW89575KF9)
  • CLOVE OIL (UNII: 578389D6D0)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
  • CINNAMON BARK OIL (UNII: XE54U569EC)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • LEMON OIL (UNII: I9GRO824LL)

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.
  • 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: Young Living Essential Oils
Labeler Code: 70631
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-26-2020 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: 12-31-2021 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.

Thieves Essential Oil-infused Chest Rub Product Label Images

Thieves Essential Oil-infused Chest Rub 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

Other

Drug Facts

Active Ingredient

Camphor 5.3%

Menthol 2.8%

Eucalyptus oil 1.3%

Purpose

Camphor .............Cough Suppressant & Topical Analgesic

Menthol ...............Cough Suppressant & Topical Analgesic

Eucalyptus oil .....Cough Suppressant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold.

Warnings

  • For external use onlyAvoid contact with eyes. Do not use • by mouth • in nostrils • on wounds or damaged skin.

Otc - Ask Doctor

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysetma

Otc - Stop Use

  • Stop use and consult a doctor if :
  • Cough persists for more than 1 week, tends to recur, is accompanied by fever, rash or persistant headache.A persistent cough may be a sign of a serious condition.

Otc - When Using

  • When using this product do not
  • Heatmicrowaveuse near open flameadd to hot water or container where heating waterMay cause splattering and result in burns.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Directions
  • See warnings under "
  • When using this product".
  • Adults and children 2 years and older. • for cough suppression • rub a thick layer on throat and chest Use up to three times daily or as directed by your doctor.Children under 2: do not use

Other Information

  • Store at room temperature (68° and 77° F).

Inactive Ingredients

Sunflower oil, Safflower oil, Castor oil, Grape seed oil, Toxicodendron succedaneum whole, Helianthus annuus seed wax, Olive oil, Tocopherol, Ascorbyl palmitate, Clove oil
†, Glyceryl linolenate, Lemon oil
†, Beta-sitosterol, Cinnamon bark oil
†, Squaline, Rosemary oil
†, Eucalyptus radiata
† leaf oil

Questions?

Questions? call 1-800-371-3515

* Please review the disclaimer below.