Fedora ORIENTAL SPA AMPOULE

Manufacturer: Fedora International Co., Ltd.
Effective date: 2015-10-26
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:43:54

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, niacinamide, etc.

OTC - PURPOSE SECTION

anti wrinklewhiteningskin protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

apply proper amount to the skin

WARNINGS SECTION

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

DOSAGE & ADMINISTRATION SECTION

for external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GLYCERIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62620-8001-1	2020-01-31	C162847	48780-1	9d75b9d0-4e9d-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62620-8001-1	Fedora ORIENTAL SPA AMPOULE	84 mL in 1 PACKAGE	LIQUID	84		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62620-8001	FEDORA ORIENTAL SPA AMPOULE (GLYCERIN) LIQUID [FEDORA INTERNATIONAL CO., LTD.]	1	Legacy NDC, 1 package rows	20151026_6dec2849-aeec-4237-a73d-0c7afb86a346.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GLYCERIN	ACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERIN	ACTIVE MOIETY	PDC6A3C0OX	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Fedora ORIENTAL SPA AMPOULE
GLYCERIN
water
NIACINAMIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62620-8001	62620-8001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	ACTIB
water	059QF0KO0R	IACT
NIACINAMIDE	25X51I8RD4	IACT

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 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	INJECTION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 4 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	INJECTION / INTRAMUSCULAR	2.5 %w/v		Exact identifier — unii candidate 4 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	GEL / TOPICAL		25 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
NIACINAMIDE	NIACINAMIDE	25X51I8RD4	CREAM / TOPICAL	NA		Exact identifier — unii candidate 4 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f498ab91-1f9e-43e8-9aa9-36942e3de081			6dec2849-aeec-4237-a73d-0c7afb86a346	2015-10-26	Warnings	Exact identifier spl id: f498ab91-1f9e-43e8-9aa9-36942e3de081 spl set id: 6dec2849-aeec-4237-a73d-0c7afb86a346

Reported adverse events (FAERS/openFDA)#

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