ATOA

Manufacturer
PROSAFEBIO
Effective date
2022-10-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:08

Label at a glance#

ProductATOA
Active ingredientRICE BRAN, SOPHORA FLAVESCENS ROOT, SCUTELLARIA BAICALENSIS ROOT, OPUNTIA HUMIFUSA WHOLE, ANGELICA GIGAS ROOT, ASIAN GINSENG
Label structure13 sections

Dosage and administration

◾Take an appropriate amount and gently spread it over. ◾Reapply it frequently on the itchy area.

Label contents#

Full prescribing information#

purpose

OTC - PURPOSE SECTION

Topical analgesic, Moisturizing, Skin protectant,Brightening

Use

INDICATIONS & USAGE SECTION

Helps moistureize and relieve itching of dry skin.

Helps strengthen the weakened skin barrier.

Warnings

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

Warnings

OTC - WHEN USING SECTION

When using this product, do not use other than directed.

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs.

Warnings

WARNINGS SECTION

For external use only

Store at room temperature and avoid direct sunlight and high temperatures.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

◾Take an appropriate amount and gently spread it over.

◾Reapply it frequently on the itchy area.

active ingredient

OTC - ACTIVE INGREDIENT SECTION

Rice Bran extract

Scutellaria baicalensis root extract

Opuntia humifusa stem extract

Sophora flavescens root extract

Angelica gigas root extract

Panax ginseng root extract

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Rice bran oil, Camellia Japonica Seed Oil, Sunflower seed oil, Glycerin, Butylene glycol, Simmondsia chinensis seed oil, Olive oil, Aloe baradensis leaf extract, Glyceryl caprylate, Centella Asiatica extract, Astragalus membranaceus root extract, Caprylyl glycol, Lavender oil, Sorbitan olivate, Xanthan gum, Ethylhexylglycerin, 1,2-Hexanediol, Disodium EDTA

Other information

OTHER SAFETY INFORMATION

Best before: 3 months after opening

Expiration date: indicated separately

Store at room temperature.

ATOA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL

81745-301

ATOAATOA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81745-301-012024-01-30C16284748780-11030e365-5699-111a-e063-dadaa90a10e2ATOA 81745-301

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81745-301-01ATOA300 mL in 1 BOTTLE, PLASTICCREAM3002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81745-301ATOA (RICE BRAN EXTRACT) CREAM [PROSAFEBIO]2Legacy NDC, 1 package rows20221021_e336ff53-04e3-0b10-e053-2995a90ab314.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81745-30181745-301-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eb82e883-b075-e9ce-e053-2995a90abb75e336ff53-04e3-0b10-e053-2995a90ab3142022-10-20WarningsExact identifier
spl id: eb82e883-b075-e9ce-e053-2995a90abb75
spl set id: e336ff53-04e3-0b10-e053-2995a90ab314

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.