Stellalife Vega Oral Care Recovery Kit
Kit
Homeocare Laboratories, Inc.
Human Otc Drug
NDC 61727-115Stellalife Vega Oral Care Recovery Kit also known as Kit is a human otc drug labeled by 'Homeocare Laboratories, Inc.'. National Drug Code (NDC) number for Stellalife Vega Oral Care Recovery Kit is 61727-115. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Stellalife Vega Oral Care Recovery Kit drug includes . The currest status of Stellalife Vega Oral Care Recovery Kit drug is Active.
Drug Information:
| Drug NDC: | 61727-115 |
| 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 Recovery Kit |
| 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: | Kit |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Homeocare Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | DENTAL
SUBLINGUAL
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: | 08 Jan, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| 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: | Homeocare Laboratories, 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. |
| UNII: | ETJ7Z6XBU4
VB06AV5US8
O80TY208ZW
QI7G114Y98
1MBW07J51Q
N94C2U587S
G0R4UBI2ZZ
1NM3M2487K
18E7415PXQ
XK4IUX8MNB
Load more...877L01IZ0P
00543AP1JV
|
| 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 |
|---|
| 61727-115-01 | 1 KIT in 1 BOX (61727-115-01) | 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. |
Purpose:
Uses temporarily relieves pain and swelling. promotes healing. reduces bruising.
Uses temporarily relieves pain and swelling. promotes healing. reduces bruising. relieves oral ulcers. hydrates oral cavity.
Usage antimicrobial promotes oral health hydrates oral cavity supports healthy gums freshens breath.
Product Elements:
Stellalife vega oral care gel gel calcium sulfide calcium sulfide strychnos ignatii seed strychnos ignatii seed delphinium staphisagria seed delphinium staphisagria seed sodium benzoate water hydroxyethyl cellulose (100 mpa.s at 2%) arnica montana arnica montana matricaria recutita matricaria recutita ruta graveolens flowering top ruta graveolens flowering top hypericum perforatum hypericum perforatum allantoin xylitol peppermint oil echinacea angustifolia echinacea angustifolia silicon dioxide silicon dioxide echinacea purpurea echinacea purpurea ledum palustre twig ledum palustre twig calendula officinalis flowering top calendula officinalis flowering top stellalife vega oral care recovery kit kit stellalife vega oral care spray calendula officinalis flowering top calendula officinalis flowering top silicon dioxide silicon dioxide citric acid monohydrate glycerin calcium sulfide calcium sulfide ledum palustre twig ledum palustre twig matricaria recutita matricaria recutita strychnos ignatii seed strychnos ignatii seed arnica montana arnica montana ruta graveolens flowering top ruta graveolens flowering top delphinium staphisagria seed delphinium staphisagria seed hypericum perforatum hypericum perforatum potassium sorbate water echinacea purpurea echinacea purpurea echinacea angustifolia echinacea angustifolia stellalife vega oral care gel gel strychnos ignatii seed strychnos ignatii seed water delphinium staphisagria seed delphinium staphisagria seed echinacea purpurea echinacea purpurea silicon dioxide silicon dioxide echinacea angustifolia echinacea angustifolia sodium benzoate calendula officinalis flowering top calendula officinalis flowering top ledum palustre twig ledum palustre twig arnica montana arnica montana ruta graveolens flowering top ruta graveolens flowering top allantoin peppermint oil xylitol hydroxyethyl cellulose (100 mpa.s at 2%) calcium sulfide calcium sulfide hypericum perforatum hypericum perforatum matricaria recutita matricaria recutita stellalife vega oral care rinse rinse polysorbate 20 peppermint oil citric acid monohydrate echinacea purpurea echinacea purpurea azadirachta indica bark azadirachta indica bark calendula officinalis flower calendula officinalis flower propolis wax allantoin mentha piperita leaf plantago major plantago major xylitol glycerin potassium sorbate water stellalife vega oral care spray calendula officinalis flowering top calendula officinalis flowering top echinacea purpurea echinacea purpurea citric acid monohydrate glycerin strychnos ignatii seed strychnos ignatii seed ruta graveolens flowering top ruta graveolens flowering top arnica montana arnica montana delphinium staphisagria seed delphinium staphisagria seed hypericum perforatum hypericum perforatum echinacea angustifolia echinacea angustifolia water potassium sorbate matricaria recutita matricaria recutita silicon dioxide silicon dioxide ledum palustre twig ledum palustre twig calcium sulfide calcium sulfide
Indications and Usage:
Usage pain and swelling relief promotes healing reduces bruising
Usage promotes healing reduces bruising relieves oral ulcers hydrates oral cavity
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.
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.
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 over 6 years of age: shake well . spray 4 times per application under the tongue . repeat 3-4 times per dday or as directed by your doctor. consult a healthcare professional for use in children under 6 years of age.
Directions adults and children over the age of 6 years: wash hands.apply to the gum at the surgical or affected area with a cotton swab. allow gel to dissolve. do not eat or drink for 20 minutes after application. apply 4 times per day or as directed by a dental professional. consult your healthcare professional for use in children under 6 years of age.
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 principal display panel rinse display
Recovery kit principal display panel kit label
Spray principal display panel spray label
Gel principal display panel gel label