Curoxen Oral Care

Olive Extract, Calendula, Clove Oil

Organicare Nature's Science, Llc
Human Otc Drug
NDC 71042-004

Curoxen Oral Care also known as Olive Extract, Calendula, Clove Oil is a human otc drug labeled by 'Organicare Nature's Science, Llc'. National Drug Code (NDC) number for Curoxen Oral Care is 71042-004. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Curoxen Oral Care drug includes Calendula Officinalis Flowering Top - 3 [hp_X]/12g Clove Oil - 1 [hp_X]/12g Olea Europaea Fruit Volatile Oil - 2 [hp_X]/12g . The currest status of Curoxen Oral Care drug is Active.

Drug Information:

Drug NDC:	71042-004
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Curoxen Oral Care
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Olive Extract, Calendula, Clove Oil
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Organicare Nature's Science, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CALENDULA OFFICINALIS FLOWERING TOP - 3 [hp_X]/12g CLOVE OIL - 1 [hp_X]/12g OLEA EUROPAEA FRUIT VOLATILE OIL - 2 [hp_X]/12g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	20 Dec, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	OrganiCare Nature's Science, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	18E7415PXQ 578389D6D0 8E7358CX1J
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
71042-004-12	1 TUBE in 1 CARTON (71042-004-12) / 12 g in 1 TUBE	20 Dec, 2017	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Curoxen Oral Care

Olive Extract, Calendula, Clove Oil

Ointment
OrganiCare Nature's Science, LLC
NDC: 71042-004

Purpose:

Purposes healing agent oral pain reliever oral antimicrobial and healing agent

Product Elements:

Curoxen oral care olive extract, calendula, clove oil cinnamon oil olive oil clove oil clove oil olea europaea fruit volatile oil olea europaea fruit volatile oil calendula officinalis flowering top calendula officinalis flowering top

Indications and Usage:

Uses for the temporary relief of pain and to help prevent infection and promote healing of: canker sores cold sores fever blisters minor irritation, injury, cuts or other sores of the mouth and gums.

Warnings:

Warnings

Dosage and Administration:

Directions adults and children of any age, apply to the affected area as needed children under 12 years of age should be supervised in the use of this product

Stop Use:

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days swelling, rash, fever or other allergic reaction develops irritation, pain or redness persists or worsens

Package Label Principal Display Panel:

Made with organic ingredients no artificial drugs or chemicals #1 oral germ killer instant pain relief curoxenÂ® oral care a homeopathic medicine that provides pain relief, speeds healing, and helps prevent infection in mouth sores pain relief and treatment of: canker sores cheek bites cold sores, and abrasions from braces & dentures mouth sore treatment pain relief healing fights infection net wt 0.42 oz (11.9 g) curoxen oral revised

Further Questions:

Questions? call 512-401-3572 or visit www.curoxen.com

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.