ANTISEPTIC- chloroxylenol soap

ANTISEPTIC by

Drug Labeling and Warnings

ANTISEPTIC 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%

PURPOSE

ANTISEPTIC

USES

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

WARNINGS

• 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.

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

OTHER INFORMATION

• STORE AT 20-25°C (60 TO 77°F)

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, PROPYLENE GLYCOL, POLYQUATERNIUM 7, GLYCOL STEARATE, SODIUM CHLORIDE, CITRIC ACID.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67106-7014
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
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
GLYCOL STEARATE (UNII: 0324G66D0E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67106-7014-1	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	03/27/2018

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(67106-7014)