FDA.reportPublic FDA data

SKY SYSTEMS - ANTISEPTIC LOTION SOAP ( 67106-7014)

Manufacturer
Sky Systems Co., Inc
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:44:44

Label at a glance#

ProductANTISEPTIC
Active ingredientCHLOROXYLENOL
Label structure9 sections

Indications and uses

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

Dosage and administration

WET HANDS AND FOREARMS. APPLY 5 ML (TEASPOONFULL) OR PALMFUL TO HANDS AND FOREARMS. SCRUB THOROUGHLY FOR 1 MINUTE. RINSE AND REPEAT.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

CHLOROXYLENOL 0.45%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

  • 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.

STOP USE 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 5 ML (TEASPOONFULL) OR PALMFUL TO HANDS AND FOREARMS.
  • SCRUB THOROUGHLY FOR 1 MINUTE. RINSE AND REPEAT.

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, GLYCOL STEARATE, SODIUM CHLORIDE, CITRIC ACID.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic 800 V2 Rev2Antiseptic 800 V2 Rev2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67106-7014-12024-06-11C16284748780-1ba0f9c33-55fd-a910-e053-dadaa90a0b85SKY SYSTEMS - ANTISEPTIC LOTION SOAP ( 67106-7014)
67106-7014-12024-01-30C16284748780-1ba0f9c33-55fd-a910-e053-dadaa90a0b85SKY SYSTEMS - ANTISEPTIC LOTION SOAP ( 67106-7014)
67106-7014-12022-12-12C16284748780-1ba0f9c33-55fd-a910-e053-dadaa90a0b85SKY SYSTEMS - ANTISEPTIC LOTION SOAP ( 67106-7014)
67106-7014-12021-01-29C16284748780-1ba0f9c33-55fd-a910-e053-dadaa90a0b85SKY SYSTEMS - ANTISEPTIC LOTION SOAP ( 67106-7014)

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
67106-701467106-7014-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
CHLOROXYLENOL0F32U78V2QACTIB
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
GLYCOL STEARATE0324G66D0EIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
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
1aa50630-49ea-9381-e063-6294a90a3af4686f5435-631c-6b5f-e053-2a91aa0a2ad92024-06-11WarningsExact identifier
spl set id: 686f5435-631c-6b5f-e053-2a91aa0a2ad9

Reported adverse events (FAERS/openFDA)#

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