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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.
Sophia Seoul Golden
FDA Label NDC 78577-122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Seoul Vietnam Cosmetics Joint Stocks Company for the product Sophia Seoul Golden (NDC 78577-122). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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.
Otc - Stop Use
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
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.
Uses
Personal hygiene convenience product, for use to wash your hands anytime, anywhere when soap and water are not available.
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
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