SOPHIA SEOUL GOLDEN- alcohol gel

Sophia Seoul Golden by

Drug Labeling and Warnings

Sophia Seoul Golden by is a Otc medication manufactured, distributed, or labeled by Seoul Vietnam Cosmetics Joint Stocks Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

Active Ingredient(s)

Ethyl Alcohol 72% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Use

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

Warnings

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

Do not use

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

WHEN USING

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.

STOP USE

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

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

Directions

• 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

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

Inactive ingredients

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

Package Label - Principal Display Panel

3785mL NDC: 78577-122-05

1000mL NDC: 78577-122-05

500mL NDC: 78577-122-04

200mL NDC: 78577-122-03

100mL NDC: 78577-122-02

50mL NDC: 78577-122-01

INGREDIENTS AND APPEARANCE

SOPHIA SEOUL GOLDEN 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78577-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78577-122-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020
2	NDC: 78577-122-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020
3	NDC: 78577-122-03	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/26/2020
4	NDC: 78577-122-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/26/2020
5	NDC: 78577-122-05	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/26/2020
6	NDC: 78577-122-06	3785 mL in 1 CAN; Type 0: Not a Combination Product	05/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/26/2020

Labeler - Seoul Vietnam Cosmetics Joint Stocks Company (556883359)

Registrant - Seoul Vietnam Cosmetics Joint Stocks Company (556883359)

Establishment
Name	Address	ID/FEI	Business Operations
Seoul Vietnam Cosmetics Joint Stocks Company		556883359	manufacture(78577-122)