FDA.reportPublic FDA data

FEDORA Oriental Spa Ampoule

Manufacturer
Fedora International Co., Ltd.
Effective date
2014-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:38

Label at a glance#

ProductFEDORA Oriental Spa Ampoule
Active ingredientGLYCERIN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

glycerin

INACTIVE INGREDIENT SECTION

Water, Glycerin, Beta-Glucan, Butylene Glycol, Glyceryl Acrylate, Acrylic Acid Copolymer, Propylene Glycol, Dimethicone, Niacinamide, Trehalose, Dipropylene Glycol, Glycosyl trehalose, Hydrolyzed Collagen, Silkworm cocoon extract, butylene glycol/Polygonum Fagopyrum Seed Extract, Aristotelia Chilensis Fruit Extract,  Phyllanthus Emblica Fruit Extract, Hippophae Rhamnoides Extract,  Pueraria Thunbergiana Root Extract, Angelica Dahurica Root Extract,  Saposhnikovia Divaricata Root Extract, Atractyloides Chinensis Rhizome Extract, Panax Ginseng Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Paeonia Lactiflora Root Extract, Astragalus Membranaceus Root Extract, Cimicifuga Dahurica Root Extract, Cryptomeria Japonica Leaf Extract, Aloe Barbadensis Leaf Extract, Ligustrum Japonicum Fruit Extract, Centella asiatica extract, Panax Ginseng Root Extract, Hippophae Rhamnoides Fruit Extract, Cornus Officinalis Fruit Extract, Gynostemma Pentaphyllum Extract, Eclipta Prostrata Extract, Caulerpa Lentillifera Extract, Codium Fragile Extract, Hamamelis Virginiana (Witch Hazel) Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Tremella Fuciformis (Mushroom) Extract, Donkey milk, Camel Milk, Xylitylglucoside, anhydroxylitol, xylitol, Sodium Hyaluronate, PEG-60 Hydrogenated castor oil, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Cholesterol, Octyldodecanol, Ubiquinone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Tremella Fuciformis Polysaccharide, Hydroxypropyl Cyclodextrin, Thioctic acid, Potassium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin, 1,2-Hexanediol, Caramel, Xanthan Gum, Adenosine, Sodium Polyacrylate, Disodium EDTA, Carbomer, Tromethamine, Lecithin, Fragrance



OTC - PURPOSE SECTION

helps your skin anti-aging and ultimate brightening solution ampoule with moisturizing


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

apply it to face and smooth the whole face using a patting motion for absorbing well


WARNINGS SECTION

avoid contact with eyes
discontinue use if signs of irritation appear


DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62620-1001-22019-11-27C16284748780-19855e2a2-34fe-60a7-e053-dbdaa90a05bdDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62620-1001-1FEDORA Oriental Spa Ampoule2 mL in 1 AMPULELIQUID21
62620-1001-2FEDORA Oriental Spa Ampoule28 in 1 PACKAGELIQUID281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62620-1001FEDORA ORIENTAL SPA AMPOULE (GLYCERIN) LIQUID [FEDORA INTERNATIONAL CO., LTD.]1Legacy NDC, 2 package rows20140307_73295be4-9adc-4f31-8ed9-15261d4bb99b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OX1
GLYCERINACTIVE MOIETYPDC6A3C0OX1
BETAINEINACTIVE INGREDIENT3SCV180C9W1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62620-100162620-1001-1, 62620-1001-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
WATER059QF0KO0RIACT
HYALURONATE SODIUMYSE9PPT4THIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BETAINE3SCV180C9WIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAVITREAL23 mgExact identifier — unii candidate
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAMUSCULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii candidate
5 equally ranked IID candidates

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
4235ae9a-79d6-4f7b-9084-571ebcb5c09273295be4-9adc-4f31-8ed9-15261d4bb99b2014-03-06WarningsExact identifier
spl id: 4235ae9a-79d6-4f7b-9084-571ebcb5c092
spl set id: 73295be4-9adc-4f31-8ed9-15261d4bb99b

Reported adverse events (FAERS/openFDA)#

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