SERVO-STAT P ANTISEPTIC HAND WASH- 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 into 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 (teaspoonful) or palmful to hands and forearms

scrub thoroughly for 1 minute and rinse

Inactive Ingredients

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Propylene Glycol, Tetrasodium EDTA, Isopropanol, Lauramine Oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin, Fragrance, Aloe Vera, FDC Blue #1, FDC Yellow #5

Servo-Stat P

Liquid Antiseptic Hand Wash

NDC # 76378-021-02

11108R-A1000

1000 ml (33.8 fl oz.)

container label

SERVO-STAT P ANTISEPTIC HAND WASH 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76378-021
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 LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
BORIC ACID (UNII: R57ZHV85D4)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76378-021-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/14/2018
2NDC:76378-021-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/14/2018
3NDC:76378-021-03946 mL in 1 BOTTLE; Type 0: Not a Combination Product12/14/2018
4NDC:76378-021-041000 mL in 1 BAG; Type 0: Not a Combination Product12/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/14/2018
Labeler - Enzyme Solutions, Inc. (004994559)
Establishment
NameAddressID/FEIBusiness Operations
Enzyme Solutions, Inc.004994559manufacture(76378-021)

Revised: 12/2018
Document Id: 343e1899-f6ef-485e-8c77-1fe72106a7ce
Set id: bf4d17d7-69c8-4844-a853-585a8f9c5eca
Version: 1
Effective Time: 20181214
 
Enzyme Solutions, Inc.