Servo-Stat by Enzyme Solutions, Inc. SERVO-STAT- alcohol gel

Servo-Stat by

Drug Labeling and Warnings

Servo-Stat 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

Ethyl Alcohol 62% (v/v)

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Use

for hand washing to decrease bacteria on the skin, only when water is not available

WARNINGS

Warnings

For external use only

Flammable. Keep away from open flame

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

apply to hands and spread vigorously

rub lightly until dry without wiping or rinsing

INACTIVE INGREDIENT

Ingredients:

Water, Triethanolamine, Carbomer, Propylene Glycol, Tocopheryl Acetate, Aloe Barbadensis

PRINCIPAL DISPLAY PANEL

Servo-Stat Rinse

Waterless Antiseptic Gel

11107R-A1000

1000 ml (33.8 fl oz.)

INGREDIENTS AND APPEARANCE

SERVO-STAT  
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76378-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76378-015-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2018
2	NDC: 76378-015-02	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2018
3	NDC: 76378-015-03	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2018
4	NDC: 76378-015-04	700 mL in 1 BAG; Type 0: Not a Combination Product	12/07/2018
5	NDC: 76378-015-05	1000 mL in 1 BAG; Type 0: Not a Combination Product	12/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/2011

Labeler - Enzyme Solutions, Inc. (004994559)

Establishment
Name	Address	ID/FEI	Business Operations
Enzyme Solutions, Inc.		004994559	manufacture(76378-015)