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, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 85% w/w

Purpose

Antiseptic

Uses

surgical hand antiseptic

significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

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 avoid contact with eyes. In case of contact with eyes, 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.

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 spead 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 Ingredients

glycerin, isopropyl alcohol, myristyl alcohol, water

PRINCIPAL DISPLAY PANEL

Sterillium

rub

fragrance-free

PROCEDURAL RUB

Surgical hand rub

Fast-acting. Dermatologically tested.

Gentle to skin.

Hand Antiseptic Rub

85% w/w ethyl alcohol with moisturizers

Surgical hand antiseptic. Significantly reduces

the number of microorganisms on the hands

and forearms prior to surgery or patient care.

Read drug facts panel before use.

Designed in Germany. Made in USA.

Lot:

Use by:

BODE

NDC: 65616-011-03

500 mL 16.91 fl. oz

INGREDIENTS AND APPEARANCE

STERILLIUM RUB FRAGRANCE-FREE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65616-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	89.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65616-011-11	2 in 1 CARTON	01/15/2025
1		500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 65616-011-12	4 in 1 CARTON	01/15/2025
2		500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 65616-011-13	8 in 1 CARTON	01/15/2025
3		500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
4	NDC: 65616-011-14	2 in 1 CARTON	01/15/2025
4		1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
5	NDC: 65616-011-15	4 in 1 CARTON	01/15/2025
5		1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
6	NDC: 65616-011-03	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2025
7	NDC: 65616-011-06	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/15/2025

Labeler - BODE Chemie GmbH (316039007)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(65616-011)