SOPHY SOAPY HAND SANITIZER- benzalkonium chloride spray

Sophy Soapy Hand Sanitizer by

Drug Labeling and Warnings

Sophy Soapy Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by General Brands, Inc., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride 0.1%

PURPOSE

Antimicrobial

INDICATIONS & USAGE

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

WARNINGS

Flammable. Keep away from fire or flame.

For external use only

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

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

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

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

STORAGE AND HANDLING

• Store in cool dry place below 104°F

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOPHY SOAPY HAND SANITIZER 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73738-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.001 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
C12-14 PARETH-12 (UNII: M0LJS773XW)
GLYCERIN (UNII: PDC6A3C0OX)
ROSEMARY (UNII: IJ67X351P9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SAGE (UNII: 065C5D077J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73738-001-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/20/2020

Labeler - General Brands, Inc. (693674187)

Registrant - General Brands, Inc. (693674187)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(73738-001)