ANTIMICROBIAL FOAM- chloroxylenol soap

ANTIMICROBIAL FOAM by

Drug Labeling and Warnings

ANTIMICROBIAL FOAM by is a Otc medication manufactured, distributed, or labeled by Sky Systems Co., Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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).

OTHER SAFETY INFORMATION

CHEMICAL EMERGENCY #: 1-800-255-3924

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL FOAM 
chloroxylenol soap

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

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

Inactive Ingredients
Ingredient Name	Strength
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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

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

Labeler - Sky Systems Co., Inc (621886548)

Registrant - Sky Systems Co., Inc (621886548)

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