SKY SYSTEMS - ANTIMICROBIAL LOTION SOAP ( 67106-7031)

Manufacturer
Sky Systems Co., Inc
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:44:42

Label at a glance#

ProductANTIMICROBIAL
Active ingredientTRICLOSAN, CHLOROXYLENOL
Label structure10 sections

Indications and uses

HELP PREVENT CROSS CONTAMINATION BY HAND CONTACT TO REDUCE INCIDENCE ON NASOCOMIAL INFECTION.

Dosage and administration

WET HANDS AND FOREARMS. APPLY A SMALL AMOUNT OF SOAP AND SCRUB THOROUGHLY FOR 1 MINUTE. RINSE THOROUGHLY. DRY HANDS COMPLETELY.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

CHLOROXYLENOL @ 0.45%

TRICLOSAN @ 0.06%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

HELP PREVENT CROSS CONTAMINATION BY HAND CONTACT TO REDUCE INCIDENCE ON NASOCOMIAL INFECTION.

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY. AVOID FOOD CONTAMINATION DURING APPLICATION AND STORAGE.

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH THE EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER.
  • AVOID CONTACT WITH BROKEN SKIN.

STOP USE OF THIS PRODUCT AND ASK A DOCTOR IF

  • CONDITIONS WORSEN OR IRRITATION PERSISTS.
  • IRRITATION OR REDNESS DEVELOPS AND PERSISTED 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 POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • WET HANDS AND FOREARMS.
  • APPLY A SMALL AMOUNT OF SOAP AND SCRUB THOROUGHLY FOR 1 MINUTE.
  • RINSE THOROUGHLY.
  • DRY HANDS COMPLETELY.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • STORE AT 20-25°C (60 TO 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, SODIUM LAURETH SULFATE, PROPYLENE GLYCOL, POLYQUATERNIUM-7, FRAGRANCE, SODIUM CHLORIDE, CITRIC ACID, COLOR DYE.

QUESTIONS?

OTC - QUESTIONS SECTION

CALL 909-923-7040

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7031 Antimicrobial Lotion Soap_UC_800mL7031 Antimicrobial Lotion Soap_UC_800mL

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67106-703167106-7031-1, 67106-7031-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
1aa4ecdb-c693-4fef-e063-6294a90a1c41249e4f94-bf58-6172-e054-00144ff8d46c2024-06-11WarningsExact identifier
spl set id: 249e4f94-bf58-6172-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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