PCMX WITH EMOLLIENT- chloroxylenol solution

PCMX with Emollient by

Drug Labeling and Warnings

PCMX with Emollient by is a Otc medication manufactured, distributed, or labeled by Aplicare Products, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

3.3% w/w Chloroxylenol

INDICATIONS & USAGE

Uses

For cleansing hands and forearms prior to surgery or patient care

PURPOSE

Antiseptic

WARNINGS

For external use only

Do not use in the eyes

Stop use and ask a doctor if

• skin shows symptoms of irritation, sensitivity, redness, pain or swelling
• discontinue use if irritation and redness develop. If condition persists more than 72 hours consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Clean under nails with nail pick. Nails should be maintained with a 1 mm free edge
• Wet hands and forearms
• Apply 5 ml or palmful to hands and forearms
• Scrub thoroughly for 3 minutes with a wet brush
• Pay particular attention to the nails, cuticles and interdigital spaces
• Rinse thoroughly with running water
• Repeat
  

Other information

• Store at room temperature
• Avoid excessive heat above 40 deg C (104 deg F)
• Protect from freezing
• Latex Free

INACTIVE INGREDIENT

Citric Acid, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Propylene Glycol, Purified Water, Sodium C12-15 Pareth-15 Sulfonate, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Sodium Laryl Sulfate, Soy Acid, Styrene/VP Copolymer

QUESTIONS

Questions?

Call: 1-800-523-0502 (Mon. - Fri. 8 AM-5 PM CST)

PRINCIPAL DISPLAY PANEL

Scrub Care 3.3% Chloroxylenol

Emmollient CLeansing Solution

INGREDIENTS AND APPEARANCE

PCMX WITH EMOLLIENT 
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-9957
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM C12-15 PARETH-15 SULFONATE (UNII: 353VA59XH8)
SOY ACID (UNII: HBA528N3PW)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
WATER (UNII: 059QF0KO0R)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-9957-3	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
2	NDC: 52380-9957-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
3	NDC: 52380-9957-9	208198 mL in 1 DRUM; Type 0: Not a Combination Product	02/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2004

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081068252	manufacture(52380-9957)