SERVO-STAT P FOAM ANTISEPTIC HAND WASH- chloroxylenol liquid

Servo-Stat P Foam Antiseptic Hand Wash by

Drug Labeling and Warnings

Servo-Stat P Foam Antiseptic Hand Wash by is a Otc medication manufactured, distributed, or labeled by Enzyme Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

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

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Use

for hand-washing to decrease bacteria on the skin

WARNINGS

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Servo-Stat P

Foam Antiseptic Hand Wash

NDC # 76378-022-02

11108R-FM1000

1000 ml (33.8fl oz.)

INGREDIENTS AND APPEARANCE

SERVO-STAT P FOAM ANTISEPTIC HAND WASH 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76378-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76378-022-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2018
2	NDC: 76378-022-02	1000 mL in 1 BAG; Type 0: Not a Combination Product	12/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/14/2018

Labeler - Enzyme Solutions, Inc. (004994559)

Establishment
Name	Address	ID/FEI	Business Operations
Enzyme Solutions, Inc.		004994559	manufacture(76378-022)