sterillium med ndc number 65616-007

SPL v6

SPL

SPL Set ID 8d80d5fd-7869-c551-e053-2995a90af2a9

Route

topical

Published

Effective Date 2023-12-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (89.5 mL)

Inactive Ingredients

glycerin isopropyl alcohol water myristyl alcohol

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2019-07-31 Until 2023-12-31

Purpose

Antiseptic

Description

Ethyl Alcohol 85% w/w

Medication Information

Warnings

For external use only.

Flammable, keep away from fire or flame.

Uses

For handwashing to decrease bacteria on the skin.
Recommended for repeated use.

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry without wiping
Supervise children in the use of this product

Inactive Ingredients

Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water.

Description

Ethyl Alcohol 85% w/w

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
condition 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 thoroughly with water.

Section 51945-4

BODE

Sterillium Med

HEALTHCARE

PERSONNEL HAND RUB

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 65615--007-06

1000 mL 33.8 fl. oz.

Active Ingredient

Ethyl Alcohol 85% w/w

Structured Label Content

Warnings

For external use only.

Flammable, keep away from fire or flame.

Uses

For handwashing to decrease bacteria on the skin.
Recommended for repeated use.

Purpose

Antiseptic

Directions

Wet hands thoroughly with product and allow to dry without wiping
Supervise children in the use of this product

Inactive Ingredients (Inactive ingredients)

Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water.

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
condition 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 thoroughly with water.

Section 51945-4 (51945-4)

BODE

Sterillium Med

HEALTHCARE

PERSONNEL HAND RUB

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 65615--007-06

1000 mL 33.8 fl. oz.

Active Ingredient (Active ingredient)

Ethyl Alcohol 85% w/w

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MYRISTYL ALCOHOL", "unii": "V42034O9PU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "89.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For handwashing 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 condition 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 thoroughly with water.", "51945-4": "BODE Sterillium Med HEALTHCARE PERSONNEL HAND RUB 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 65615--007-06 1000 mL 33.8 fl. oz.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable, keep away from fire or flame.", "Directions": "Wet hands thoroughly with product and allow to dry without wiping Supervise children in the use of this product", "Active ingredient": "Ethyl Alcohol 85% w/w", "Inactive ingredients": "Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:02.359708 · Updated: 2026-03-14T23:08:30.723878