ANTIMICROBIAL- chloroxylenol soap

ANTIMICROBIAL by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

• 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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

• IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

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

OTHER INFORMATION

• STORE AT 20-25°C (60 TO 77°F)

INACTIVE INGREDIENTS

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

QUESTIONS?

CALL 909-923-7040

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67106-7031
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
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.06 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67106-7031-8	12 in 1 BOX	12/10/1990
1	NDC: 67106-7031-1	800 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/10/1990

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(67106-7031)