ANTIMICROBIAL FOAM- 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 FOAM SOAP (67106-7231)

ACTIVE INGREDIENTS

CHLOROXYLENOL 0.45%

PURPOSE

ANTISEPTIC

USES

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

WARNINGS

FOR EXTERNAL USE ONLY. AVOID ANY FOODS CONTAMINATION DURING APPLICATION AND STORAGE.

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 IRRITATION OR REDNESS DEVELOPS OR CONDITION PERSISTS FOR MORE THAN 72 HOURS.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

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

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, PROPYLENE GLYCOL, POLYQUATERNIUM 7, FRAGRANCE, CITRIC ACID, FD&C YELLOW #5 (CAS #1934-21-0), FD&C rED #4 (CAS #548-53-2), D&C RED #33 (CAS #567-66-6), FD&C BLUE #1 (CAS #3844-15-9).

CHEMICAL EMERGENCY #: 1-800-255-3924

Antimicrobial Foam Soap Label

ANTIMICROBIAL FOAM
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67106-7231
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.45 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67106-7231-1	800 mL in 1 BOX; Type 0: Not a Combination Product	03/29/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/29/2018

Labeler - Sky Systems Co., Inc (621886548)

Registrant - Sky Systems Co., Inc (621886548)

Name	Address	ID/FEI	Business Operations
Establishment
Sky Systems Co., Inc		621886548	manufacture(67106-7231)