Sterillium Foam 65616-006

SPL v8

SPL

SPL Set ID 93680cd8-609f-48f2-e053-2995a90aa355

Route

TOPICAL

Published

Effective Date 2026-03-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (85 mL)

Inactive Ingredients

Bis-peg/ppg-20/20 Dimethicone Isopropyl Alcohol Myristyl Alcohol Water Cyclomethicone Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-09-25

Description

Ethyl Alcohol 85 % v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 85 % v/v

Uses

To decrease bacteria on the skin.
Recommended for repeated use.

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

irritation and redness develop
conditions persists for more than 72 hours

Section 50570-1

Do not usein or near the eyes or on mucous membranes.

In case of contact, rinse thoughly with water.

Section 51945-4

Sterillium

foam

Healthcare Personnel Hand Antiseptic

Kills > 99.999% of germs

in 15 seconds without water.

Dermatologically tested. Fragrance Free

Hand Antiseptic Foam

85% v/v ethyl alcohol with moisturizers

To decrease bacteria on the skin.

Recommended for repeated use.

Read drug facts panel before use.

Designed in Germany. Made in USA.

Lot:

Use by:

BODE

NDC 65616-006-03 500 mL 16.91 fl. oz

Warnings

For external use only.

Flammable, keep away from fire or flame.

Directions

Apply to clean, dry hands, covering entire surface, including nails
Rub until dry
Supervise children in the use of this product

Active Ingredient

Ethyl Alcohol 85 % v/v

Inactive Ingredients

Bis-PEG/PPG-20/20 Dimethicone, Cyclomethicone, Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water.

Structured Label Content

Uses

To decrease bacteria on the skin.
Recommended for repeated use.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

irritation and redness develop
conditions persists for more than 72 hours

Section 50570-1 (50570-1)

Do not usein or near the eyes or on mucous membranes.

In case of contact, rinse thoughly with water.

Section 51945-4 (51945-4)

Sterillium

foam

Healthcare Personnel Hand Antiseptic

Kills > 99.999% of germs

in 15 seconds without water.

Dermatologically tested. Fragrance Free

Hand Antiseptic Foam

85% v/v ethyl alcohol with moisturizers

To decrease bacteria on the skin.

Recommended for repeated use.

Read drug facts panel before use.

Designed in Germany. Made in USA.

Lot:

Use by:

BODE

NDC 65616-006-03 500 mL 16.91 fl. oz

Purpose

Antiseptic

Warnings

For external use only.

Flammable, keep away from fire or flame.

Directions

Apply to clean, dry hands, covering entire surface, including nails
Rub until dry
Supervise children in the use of this product

Active Ingredient (Active ingredient)

Ethyl Alcohol 85 % v/v

Inactive Ingredients (Inactive ingredients)

Bis-PEG/PPG-20/20 Dimethicone, Cyclomethicone, Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water.

Advanced Ingredient Data

[{"name": "BIS-PEG/PPG-20/20 DIMETHICONE", "unii": "05W209DSBS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MYRISTYL ALCOHOL", "unii": "V42034O9PU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE", "unii": "NMQ347994Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "85", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "To decrease bacteria on the skin. Recommended for repeated use.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation and redness develop conditions persists for more than 72 hours", "50570-1": "Do not use in or near the eyes or on mucous membranes. In case of contact, rinse thoughly with water.", "51945-4": "Sterillium foam Healthcare Personnel Hand Antiseptic Kills > 99.999% of germs in 15 seconds without water. Dermatologically tested. Fragrance Free Hand Antiseptic Foam 85% v/v ethyl alcohol with moisturizers To decrease bacteria on the skin. Recommended for repeated use. Read drug facts panel before use. Designed in Germany. Made in USA. Lot: Use by: BODE NDC 65616-006-03 500 mL 16.91 fl. oz", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable, keep away from fire or flame.", "Directions": "Apply to clean, dry hands, covering entire surface, including nails Rub until dry Supervise children in the use of this product", "Active ingredient": "Ethyl Alcohol 85 % v/v", "Inactive ingredients": "Bis-PEG/PPG-20/20 Dimethicone, Cyclomethicone, Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.588655 · Updated: 2026-03-14T23:14:11.403934