SERVO-STAT T - triclosan 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

Triclosan 0.3%

Purpose

Antiseptic

Use

for hand-washing to decrease bacteria on the skin


Warnings

For external use only

When using 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 (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, Sodium Chloride, Tetrasodium EDTA, Isopropanol, Lauramine Oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin and PCMX (Preservatives), Fragrance, Aloe Vera, FDC Blue #1, FDC Yellow #5

Servo-Stat T

Antiseptic Hand Wash

1105R-A1000

1000 ml (33.8 fl oz.)

container label

SERVO-STAT T 
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76378-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
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)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
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:76378-012-01473 mL in 1 BOTTLE
2NDC:76378-012-02946 mL in 1 BOTTLE
3NDC:76378-012-031000 mL in 1 BAG
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

Revised: 8/2011
Document Id: 9140f7cc-cb62-4857-a084-c119435e9c35
Set id: e8ddc533-5acf-4aa0-b128-20da4ff25a40
Version: 1
Effective Time: 20110829
 
Enzyme Solutions, Inc.