SERVO-STAT P - chloroxylenol liquid 
Enzyme Solutions, 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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Drug Facts

Active Ingredient

PCMX (para-chloro-meta-xylenol) 0.6%

Purpose

Antiseptic

Use

for hand-washing to decrease bacteria on the skin

Warnings

For external use only

When using this product

Do not get in eyes

If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

Irritation and redness develop

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Ready to use

Do not dilute

Wet hands and forearms

Apply 5 milliliters (palmful) to hands and forearms

Rinse thoroughly

Ingredients

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Tetrasodium EDTA, Propylene Glycol, Fragrance, Sodium Chloride, Boric Acid, Glycol Stearate, PEG-75 Lanolin, DMDM Hydantoin, Aloe Vera, FDC Red #40, FDC Yellow #6

Servo-Stat P

Antiseptic Hand Wash

11106R-A1000

1000 ml (33.8 fl oz.)

container label

SERVO-STAT P 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76378-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BORIC ACID (UNII: R57ZHV85D4)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76378-017-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2018
2NDC:76378-017-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2018
3NDC:76378-017-03946 mL in 1 BOTTLE; Type 0: Not a Combination Product12/07/2018
4NDC:76378-017-041000 mL in 1 BAG; Type 0: Not a Combination Product12/07/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/2011
Labeler - Enzyme Solutions, Inc. (004994559)
Establishment
NameAddressID/FEIBusiness Operations
Enzyme Solutions, Inc.004994559manufacture(76378-017)

Revised: 12/2018
Document Id: d65d4642-de26-4369-bdd1-65684de5cb50
Set id: 3dcdaa90-3db0-4442-9a73-d1751133b342
Version: 2
Effective Time: 20181207
 
Enzyme Solutions, Inc.