Intime Cesens

Nartex Laboratorios Homeopaticos Sa De Cv
Human Otc Drug
NDC 34666-301

Intime Cesens is a human otc drug labeled by 'Nartex Laboratorios Homeopaticos Sa De Cv'. National Drug Code (NDC) number for Intime Cesens is 34666-301. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Intime Cesens drug includes Calendula Officinalis Whole - 1 [hp_X]/g Hamamelis Virginiana Whole - 3 [hp_X]/g Hydrastis Canadensis Whole - 5 [hp_X]/g Matricaria Chamomilla - 1 [hp_X]/g . The currest status of Intime Cesens drug is Active.

Drug Information:

Drug NDC:	34666-301
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:	Intime Cesens
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:	Intime Cesens
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Nartex Laboratorios Homeopaticos Sa De Cv
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
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 WHOLE - 1 [hp_X]/g HAMAMELIS VIRGINIANA WHOLE - 3 [hp_X]/g HYDRASTIS CANADENSIS WHOLE - 5 [hp_X]/g MATRICARIA CHAMOMILLA - 1 [hp_X]/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TRANSDERMAL
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:	11 Jun, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	12 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, 2023
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:	Nartex Laboratorios Homeopaticos SA DE CV
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.
UPC:	0844827001174
UPC stands for Universal Product Code.
UNII:	PFR03EBU0H V663Q8TEFU R763EBH88T G0R4UBI2ZZ
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
34666-301-01	29.7 g in 1 TUBE (34666-301-01)	11 Jun, 2020	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

Intime Cesens

Gel
Nartex Laboratorios Homeopaticos SA DE CV
NDC: 34666-301

Purpose:

Purpose calendula officinalis tinc hpus*......external vaginal burning chamomilla tinc hpus*.....burning and vulvar itching hamamelis virginiana 3x hpus*.....external vaginal irritation hydrastis canadensis 5x hpus*.....itching and vulvar pruritis

Product Elements:

Intime cesens intime cesens hydrastis canadensis whole hydrastis canadensis whole hamamelis virginiana whole hamamelis virginiana whole matricaria chamomilla matricaria chamomilla lavender oil sodium benzoate citric acid monohydrate glycerin xanthan gum water calendula officinalis whole calendula officinalis whole potassium sorbate aloe vera leaf propylene glycol

Indications and Usage:

Uses temporary relief of external vaginal burning itching irritation. claims based on traditional homeopathic practice, not accepted medical evidence. these uses have not been evaluated by fda, and product has not been clinically tested.

Warnings:

Warnings for external use only

Do Not Use:

Warnings for external use only

When Using:

When using this product avoid contact with eyes or mucous membranes

Dosage and Administration:

Directions adults, cleanse the affected area with an appropriate cleansing wipe apply generously to affeted area up to 2 times daily reappy if needed

Stop Use:

Stop use and ask a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days rash develops.

Package Label Principal Display Panel:

Principal display panel contains witch hazel intime cesens calendula, chamomila, hamamelis & hydrastis gel temporary relief of external vaginal burning, itching and irritation. fragrance free. with lavender essential oil. paraben free for external use only claims based on traditional homeopathic practice, not acceptd medical evidence. not fda evaluated and not clinically tested. homeopathic net wt. 1.05oz (29.7g) pdp

Further Questions:

Questions or comments? informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm cst.

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.