Sterillium Rub by Bode Chemie Hamburg Drug Facts

Sterillium Rub by

Drug Labeling and Warnings

Sterillium Rub by is a Otc medication manufactured, distributed, or labeled by Bode Chemie Hamburg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STERILLIUM RUB- surgical hand antiseptic liquid 
Bode Chemie Hamburg

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                        Purpose

Ethanol 80% w/w.......................Antiseptic

Active Ingredient                        Purpose

Ethanol 80% w/w.......................Antiseptic

Uses

surgical hand antiseptic

significantly reduces the number of micro-organisms 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 eyes or on mucous membranes.

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

Stop use and ask a doctor if

irritation and redness develop

conditions 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 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. 2 minutes

Inactive Ingredients

Ethylhexyl Ethylhexanoate, Fragrance, Isohexadecane, Lanolin Alcohol, Myristyl Alcohol, PCA, Sodium PCA, Water.

Sterillium Rub

Procedural Scrub

Surgical Hand Antiseptic

80% ethyl alcohol w/w with emollients

Indication: Significantly reduces the number of micro-organisms on the hands andforearms 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, 7 a.m.-7 p.m. CST

1000 mL 33.8 fl. oz.

STERILLIUM RUB 
surgical hand antiseptic liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65616-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MYRISTYL ALCOHOL (UNII: V42034O9PU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65616-001-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2003
2	NDC: 65616-001-06	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2003
3	NDC: 65616-001-08	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2003	10/31/2011

Labeler - Bode Chemie Hamburg (316039007)

Establishment
Name	Address	ID/FEI	Business Operations
Bode Chemie Hamburg		316039007	manufacture(65616-001)

Revised: 11/2019

Document Id: 96b2fe5d-8fc6-57c3-e053-2995a90adca2

34390-5

Set id: e72c445c-df04-4d37-bd33-f495a3688104

Version: 2

Effective Time: 20191106

 

Bode Chemie Hamburg