FDA.reportPublic FDA data

99X

Manufacturer
Southern Products and Services, Inc
Effective date
2022-07-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:56:36

Label at a glance#

Product99X
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

• For hand sanitizing to decrease bacteria on the skin • Recommended for repeated use

Dosage and administration

• Pump a small amount of foam into palm of hand • Rub thoroughly over all surfaces of both hands • Rub hands together briskly until dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%.

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION


• For hand sanitizing to decrease bacteria on the skin
• Recommended for repeated use

Warnings

WARNINGS SECTION


For external use only
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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


• Pump a small amount of foam into palm of hand
• Rub thoroughly over all surfaces of both hands
• Rub hands together briskly until dry

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, cocamidopropyl PG-dimonium chloride phosphate, dihydroxyethyl cocamine oxide, acetamidoethoxyethanol, citric acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

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
82738-25082738-250-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMIDOETHOXYETHANOLLVX2APC4XRIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
DIHYDROXYETHYL COCAMINE OXIDE8AR51R3BL5IACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
e5fd29f0-c755-553a-e053-2a95a90a1b0ae42e8855-2dbd-58b1-e053-2995a90a27a12022-08-11WarningsExact identifier
spl set id: e42e8855-2dbd-58b1-e053-2995a90a27a1

Reported adverse events (FAERS/openFDA)#

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