STERILLIUM MED- alcohol liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
BODE Chemie GmbH
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - For handwashing to decrease bacteria on the skin. - Recommended for repeated use. Do not use in or near the eyes or on mucous membranes. In case of contact, rinse thoroughly with water. Stop use and ask a doctor if - irritation and redness develop - condition persists for more than 72 hours
Authorization status:
OTC monograph not final
Authorization number:
65616-007-03, 65616-007-06, 65616-007-08

STERILLIUM MED- alcohol liquid

BODE Chemie GmbH

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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Sterillium Med NDC Number 65616-007

Active ingredient

Ethyl Alcohol 85% w/w

Purpos e

Antiseptic

Us es

For handwashing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame.

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

In case of contact, rinse thoroughly 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, covering entire surface, including nails

Rub until dry

Supervise children in the use of this product

Inactive ingredients

Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water.

BODE

Sterillium Med

HEALTHCARE PERSONNEL

HAND ANTISEPTIC

85% w/w ethyl alcohol with moisturizers

Kills >99.999% of germs in 15 seconds without water.

Leaves hands feeling soft and healthy.

Dermatologically tested.

Read Drug Facts panel before use.

Liquid formula with

95% natural ingredients

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC 65616-007-06

1000 mL 33.8 fl. oz.

Container labelF

STERILLIUM MED

alcohol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 56 16 -0 0 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BODE Chemie GmbH

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

8 9 .5 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

WATER (UNII: 0 59 QF0 KO0 R)

MYRISTYL ALCO HO L (UNII: V420 34O9 PU)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 56 16 -0 0 7-

50 0 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/31/20 19

2

NDC:6 56 16 -0 0 7-

10 0 0 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/31/20 19

3

NDC:6 56 16 -0 0 7-

50 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/31/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 7/31/20 19

Labeler -

BODE Chemie GmbH (316039007)

Revised: 6/2020

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