Atoa

Rice Bran Extract

Prosafebio
Human Otc Drug
NDC 81745-301

Atoa also known as Rice Bran Extract is a human otc drug labeled by 'Prosafebio'. National Drug Code (NDC) number for Atoa is 81745-301. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Atoa drug includes Angelica Gigas Root - 1 g/100mL Asian Ginseng - .5 g/100mL Opuntia Humifusa Whole - 1 g/100mL Rice Bran - 4 g/100mL Scutellaria Baicalensis Root - 1 g/100mL Sophora Flavescens Root - 1 g/100mL . The currest status of Atoa drug is Active.

Drug Information:

Drug NDC:	81745-301
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:	Atoa
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:	Rice Bran Extract
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Prosafebio
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
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:	ANGELICA GIGAS ROOT - 1 g/100mL ASIAN GINSENG - .5 g/100mL OPUNTIA HUMIFUSA WHOLE - 1 g/100mL RICE BRAN - 4 g/100mL SCUTELLARIA BAICALENSIS ROOT - 1 g/100mL SOPHORA FLAVESCENS ROOT - 1 g/100mL
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 DRUG OTHER
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:	07 Jul, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	04 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:	PROSAFEBIO
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:	32766B2FHX CUQ3A77YXI 6E9O5V4SS5 R60QEP13IC 7J95K7ID2S IYR6K8KQ5K
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
81745-301-01	300 mL in 1 BOTTLE, PLASTIC (81745-301-01)	07 Jul, 2022	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

Atoa

Rice Bran Extract

Cream
PROSAFEBIO
NDC: 81745-301

Purpose:

Purpose topical analgesic, moisturizing, skin protectant,brightening

Product Elements:

Atoa rice bran extract glycerin xanthan gum edetate disodium anhydrous camellia japonica seed oil caprylyl glycol sorbitan olivate sunflower oil butylene glycol aloe vera leaf astragalus propinquus root polysaccharides ethylhexylglycerin 1,2-hexanediol rice bran rice bran glyceryl caprate centella asiatica simmondsia chinensis seed olive oil sophora flavescens root sophora flavescens root rice bran oil scutellaria baicalensis root scutellaria baicalensis root opuntia humifusa whole opuntia humifusa whole angelica gigas root angelica gigas root asian ginseng asian ginseng water lavender oil

Indications and Usage:

Use helps moistureize and relieve itching of dry skin. helps strengthen the weakened skin barrier.

Warnings:

Warnings for external use only store at room temperature and avoid direct sunlight and high temperatures.

Do Not Use:

Warnings for external use only store at room temperature and avoid direct sunlight and high temperatures.

When Using:

Warnings when using this product, do not use other than directed.

Dosage and Administration:

Directions â¾take an appropriate amount and gently spread it over. â¾reapply it frequently on the itchy area.

Stop Use:

Warnings stop use and ask a doctor if irritation occurs.

Package Label Principal Display Panel:

Atoa label 81745-301 atoa

Further Questions:

Question? comments? 070-7576-2728 https://prosafebio.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.