ANTIMICROBIAL- chloroxylenol soap 
Sky Systems Co., Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SKY SYSTEMS - ANTIMICROBIAL LOTION SOAP ( 67106-7031)

ACTIVE INGREDIENT

CHLOROXYLENOL @ 0.45%

TRICLOSAN @ 0.06%

PURPOSE

ANTISEPTIC

USES

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

WARNINGS

WHEN USING THIS PRODUCT

STOP USE OF THIS PRODUCT AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

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

QUESTIONS?

CALL 909-923-7040

7031 Antimicrobial Lotion Soap_UC_800mL

ANTIMICROBIAL 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67106-7031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.06 g  in 100 mL
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.45 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67106-7031-812 in 1 BOX12/10/1990
1NDC:67106-7031-1800 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/10/1990
Labeler - Sky Systems Co., Inc (621886548)
Registrant - Sky Systems Co., Inc (621886548)
Establishment
NameAddressID/FEIBusiness Operations
Sky Systems Co., Inc621886548manufacture(67106-7031)

Revised: 12/2022
Document Id: efa9eef4-c57c-e626-e053-2a95a90a6838
Set id: 249e4f94-bf58-6172-e054-00144ff8d46c
Version: 3
Effective Time: 20221212
 
Sky Systems Co., Inc