FDA.reportPublic FDA data

Sophia Seoul Golden

Manufacturer
Seoul Vietnam Cosmetics Joint Stocks Company
Effective date
2020-06-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:16:06

Label at a glance#

ProductSophia Seoul Golden
Active ingredientALCOHOL
Label structure14 sections

Indications and uses

Personal hygiene convenience product, for use to wash your hands anytime, anywhere when soap and water are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store in cool, dry place Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 72% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Personal hygiene convenience product, for use to wash your hand anytime, anywhere when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store in cool, dry place
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Propylene glycol, glycerin, carbomer, triethanolamine, aloe barbadensis leaft juice.

Uses

RECENT MAJOR CHANGES SECTION

Personal hygiene convenience product, for use to wash your hands anytime, anywhere when soap and water are not available.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785mL NDC: 78577-122-05

3785 ml label3785 ml label

1000mL NDC: 78577-122-05

1000 mL label1000 mL label

500mL NDC: 78577-122-04

500 mL label500 mL label

200mL NDC: 78577-122-03

200 mL label200 mL label

100mL NDC: 78577-122-02

100 mL label100 mL label

50mL NDC: 78577-122-01 50ml Label50ml Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78577-122-012022-01-28C16284748780-1d6a99b39-8df2-a426-e053-dadaa90af4c2a610056c-7c9c-c3db-e053-2a95a90ad5e1
78577-122-022022-01-28C16284748780-1d6a99b39-8df2-a426-e053-dadaa90af4c2a610056c-7c9c-c3db-e053-2a95a90ad5e1
78577-122-032022-01-28C16284748780-1d6a99b39-8df2-a426-e053-dadaa90af4c2a610056c-7c9c-c3db-e053-2a95a90ad5e1
78577-122-042022-01-28C16284748780-1d6a99b39-8df2-a426-e053-dadaa90af4c2a610056c-7c9c-c3db-e053-2a95a90ad5e1
78577-122-052022-01-28C16284748780-1d6a99b39-8df2-a426-e053-dadaa90af4c2a610056c-7c9c-c3db-e053-2a95a90ad5e1
78577-122-062022-01-28C16284748780-1d6a99b39-8df2-a426-e053-dadaa90af4c2a610056c-7c9c-c3db-e053-2a95a90ad5e1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78577-122-01Sophia Seoul Golden50 mL in 1 BOTTLE, PLASTICGEL503
78577-122-02Sophia Seoul Golden100 mL in 1 BOTTLE, PLASTICGEL1003
78577-122-03Sophia Seoul Golden200 mL in 1 BOTTLE, PUMPGEL2003
78577-122-04Sophia Seoul Golden500 mL in 1 BOTTLE, PUMPGEL5003
78577-122-05Sophia Seoul Golden1000 mL in 1 BOTTLE, PUMPGEL10003
78577-122-06Sophia Seoul Golden3785 mL in 1 CANGEL37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78577-122SOPHIA SEOUL GOLDEN (ALCOHOL) GEL [SEOUL VIETNAM COSMETICS JOINT STOCKS COMPANY]3Legacy NDC, 6 package rows20200605_a610056c-7c9c-c3db-e053-2a95a90ad5e1.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78577-12278577-122-01, 78577-122-02, 78577-122-03, 78577-122-04, 78577-122-05, 78577-122-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
a74044b2-ff6e-403d-e053-2a95a90ab5b0a610056c-7c9c-c3db-e053-2a95a90ad5e12020-06-04WarningsExact identifier
spl id: a74044b2-ff6e-403d-e053-2a95a90ab5b0
spl set id: a610056c-7c9c-c3db-e053-2a95a90ad5e1

Reported adverse events (FAERS/openFDA)#

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