FDA.reportPublic FDA data

Sophy Soapy Hand Sanitizer

Manufacturer
General Brands, Inc. | Kolmar Korea Co.,LTD. Gwanjeong Factory
Effective date
2020-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:38:48

Label at a glance#

ProductSophy Soapy Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Storage and handling

Store in cool dry place below 104°F

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS & USAGE SECTION

  • ■ To reduce disease-causing bacteria on the skin ■ To disinfect hard surfaces ■ Recommended for repeated use

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only

OTC - WHEN USING SECTION

When using this product ■Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water ■ Avoid contact with broken skin ■ Do not inhale or ingest ■ Keep away from fire or flame

OTC - STOP USE SECTION

Stop use and ask a doctor if ■ Irritation or redness occurs ■Condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children ■ Children under 6years of age should be supervised when using this product ■ If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

■Spray enough product in your palms to cover your hands ■ Rub together until dry

STORAGE AND HANDLING SECTION

  • Store in cool dry place below 104°F

INACTIVE INGREDIENT SECTION

water, alcohol, peg-40 hydrogenated castor oil, c12-14 pareth-12, fragrance, glycerin, rosmarinus officinalis (rosemary) leaf extract, citric acid, sodium benzoate, butylene glycol, salvia officinalis (sage) leaf extract, phenoxyethanol, ethylhexylglycerin, sodium citrate, disodium edta, simmondsia chinensis (jojoba) seed oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73738-001-012023-05-10C16284748780-1d6a99b39-bbb7-a426-e053-dadaa90af4c2Sophy soapy hand sanitizer
73738-001-012022-01-28C16284748780-1d6a99b39-bbb7-a426-e053-dadaa90af4c2Sophy soapy hand sanitizer

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73738-00173738-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
C12-14 PARETH-12M0LJS773XWIACT
GLYCERINPDC6A3C0OXIACT
ROSEMARYIJ67X351P9IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SAGE065C5D077JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
EDETATE DISODIUM7FLD91C86KIACT
JOJOBA OIL724GKU717MIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
fb607656-ed99-40e2-e053-6394a90a418997b7a0af-9993-4e88-b856-75a032952a7b2023-05-10WarningsExact identifier
spl set id: 97b7a0af-9993-4e88-b856-75a032952a7b

Reported adverse events (FAERS/openFDA)#

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