65616-010

65616-010
SPL v1
SPL
SPL Set ID 2d48dab8-f70a-a2b5-e063-6294a90a1456
Route
TOPICAL
Published
Effective Date 2025-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (85 mL)
Inactive Ingredients
Isopropyl Alcohol Glycerin Myristyl Alcohol Cyclomethicone Carbomer Interpolymer Type A (55000 Cps) Edetol Povidone K90 Water Isohexadecane Levomenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-03
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

• condition persists for more than 72 hours

Section 50570-1

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

In case of contact, rinse thoroughly with water.

Section 51945-4

Sterillium

comfort gel

Healthcare personnel Hand Rub

Kills > 99.999% of germs

in 15 seconds without water.

Boosts skin moisture level.

Leaves hands feeling soft and healthy.

Dermatologically tested.

Hand Antiseptic Gel

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 65616-010-09

475 mL 16.06 fl. oz

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 % v/v

Inactive Ingredients

acrylates/C 10-30 alkyl acrylate crosspolymer, bisabolol, cyclomethicone, glycerin, isohexadecane, isopropyl alcohol, myristyl alcohol, PVP, tetrahydroxypropyl ethylenediamine, 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

• condition persists for more than 72 hours

Section 50570-1 (50570-1)

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

In case of contact, rinse thoroughly with water.

Section 51945-4 (51945-4)

Sterillium

comfort gel

Healthcare personnel Hand Rub

Kills > 99.999% of germs

in 15 seconds without water.

Boosts skin moisture level.

Leaves hands feeling soft and healthy.

Dermatologically tested.

Hand Antiseptic Gel

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 65616-010-09

475 mL 16.06 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 (Active ingredient)

Ethyl Alcohol 85 % v/v

Inactive Ingredients (Inactive ingredients)

acrylates/C 10-30 alkyl acrylate crosspolymer, bisabolol, cyclomethicone, glycerin, isohexadecane, isopropyl alcohol, myristyl alcohol, PVP, tetrahydroxypropyl ethylenediamine, water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:28.445394 · Updated: 2026-03-14T23:07:22.014703