Stellalife Vega Oral Care Coconut

Risne

Stellalife, Inc.
Human Otc Drug
NDC 69685-113

Stellalife Vega Oral Care Coconut also known as Risne is a human otc drug labeled by 'Stellalife, Inc.'. National Drug Code (NDC) number for Stellalife Vega Oral Care Coconut is 69685-113. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Stellalife Vega Oral Care Coconut drug includes Apis Mellifera - 12 [hp_X]/mL Azadirachta Indica Bark - 1 [hp_X]/mL Calendula Officinalis Flower - 1 [hp_X]/mL Echinacea Purpurea - 1 [hp_X]/mL Okoubaka Aubrevillei Bark - 6 [hp_X]/mL Phosphorus - 12 [hp_X]/mL Plantago Major - 1 [hp_X]/mL Strontium - 30 [hp_X]/mL Thuja Occidentalis Leafy Twig - 3 [hp_X]/mL . The currest status of Stellalife Vega Oral Care Coconut drug is Active.

Drug Information:

Drug NDC:	69685-113
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:	Stellalife Vega Oral Care Coconut
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:	Risne
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Stellalife, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Rinse
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:	APIS MELLIFERA - 12 [hp_X]/mL AZADIRACHTA INDICA BARK - 1 [hp_X]/mL CALENDULA OFFICINALIS FLOWER - 1 [hp_X]/mL ECHINACEA PURPUREA - 1 [hp_X]/mL OKOUBAKA AUBREVILLEI BARK - 6 [hp_X]/mL PHOSPHORUS - 12 [hp_X]/mL PLANTAGO MAJOR - 1 [hp_X]/mL STRONTIUM - 30 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG - 3 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	DENTAL
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:	08 Jan, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	09 May, 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:	StellaLife, Inc.
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:	0850019861020
UPC stands for Universal Product Code.
NUI:	N0000185021 N0000175629 N0000184306 N0000185001 M0000728 M0002274
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	7S82P3R43Z G580B439YI P0M7O4Y7YD QI7G114Y98 MK2074187Z 27YLU75U4W W2469WNO6U YZS2RPE8LE 1NT28V9397
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.
Pharmacologic Class EPC:	Standardized Insect Venom Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS] Bee Venoms [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Bee Venoms [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Standardized Insect Venom Allergenic Extract [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
69685-113-16	1 BOTTLE, PLASTIC in 1 BOX (69685-113-16) / 473 mL in 1 BOTTLE, PLASTIC	08 Jan, 2021	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

Stellalife Vega Oral Care Coconut

Risne

Rinse
Homeocare Laboratories, Inc.
NDC: 61727-119

Stellalife Vega Oral Care Coconut

Risne

Rinse
StellaLife, Inc.
NDC: 69685-113

Purpose:

Usage antimicrobial promotes oral health hydrates oral cavity supports healthy gums freshens breath.

Product Elements:

Stellalife vega oral care coconut risne xylitol calendula officinalis flower calendula officinalis flower apis mellifera apis mellifera propolis wax potassium sorbate coconut citric acid monohydrate azadirachta indica bark azadirachta indica bark thuja occidentalis leafy twig thuja occidentalis leafy twig allantoin water echinacea purpurea echinacea purpurea phosphorus phosphorus plantago major plantago major glycerin strontium strontium okoubaka aubrevillei bark okoubaka aubrevillei bark

Indications and Usage:

Uses promotes oral health hydrates oral cavity supports healthy gums freshens breath

Warnings:

Warnings do not use if you have a known allergy or sensitivity to any of the following ingredients stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash. as with any drug, if you are pregnant or nursing a baby, seek the advise of a healthcare professional before using this product. keep this and all drugs out of the reach of children. in case of accidental overdose, seek professional assistance or contact poison control center immediately. if pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.

Dosage and Administration:

Directions adults and children ovver the age of 6 years: shake well. use 3/4 tablespoon (10 ml) per application 3 times a day. swish in the mouth for 1-2 minutes abnd then spit out. do not swallow. refrain from eating or drinking for at least 20 minutes after use. consult your healthcare professional for use in children under 6 years of age.

Package Label Principal Display Panel:

Rinse box

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.