STERILLIUM RUB FRAGRANCE FREE- alcohol liquid

Sterillium Rub Fragrance Free by

Drug Labeling and Warnings

Sterillium Rub Fragrance Free by is a Otc medication manufactured, distributed, or labeled by BODE Chemie GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 85% w/w

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

surgical hand antiseptic

significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

WARNINGS

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use in or near the eyes or on mucous membranes.

When using this product and contact with the eyes occurs, flush immediately with water.

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

apply to clean, dry hands

for the first use of the day, use a nail pick

dispense approx. 2 mL into hand, dip fingers of opposite hand into palm, working product under nails and into cuticles

repeat procedure with other hand

with hands still moist spread around the hand and lower 1/3 of the forearm

reapply the product to the hands, paying particular attention to fingers, cuticles, and interdigital spaces

following application, rub hands until dry

hands should remain moist for entire application time, approx. 1.5 minutes.

INACTIVE INGREDIENT

Inactive Ingredients

Water, n-Propyl Alcohol, Myristyl Alcohol, Methylethylketone, Glycerin.

PRINCIPAL DISPLAY PANEL

Bode

Sterillium Rub

Fragrance-Free

Procedural Scrub

Surgical

Hand Antiseptic

85% w/w ethyl alcohol with emollients

Indication: Significantly reduces the number

of micro-organisms on the hands and forearms

prior to surgery or patient care.

Fast-acting. Dermatologically tested.

Gentle to skin.

Read Drug Facts panel before use.

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC: 65616-004-06

1000 ml 33.8 fl. oz.

INGREDIENTS AND APPEARANCE

STERILLIUM RUB FRAGRANCE FREE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65616-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	85 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYL ALCOHOL (UNII: 96F264O9SV)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
METHYL ETHYL KETONE (UNII: 6PT9KLV9IO)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65616-004-06	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/28/2012
2	NDC: 65616-004-08	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/28/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/28/2012	04/01/2021

Labeler - BODE Chemie GmbH (316039007)

Establishment
Name	Address	ID/FEI	Business Operations
BODE Chemie GmbH		316039007	manufacture(65616-004)