Sterillium Comfort Gel Ndc 65616-009

Sterillium Comfort Gel Ndc 65616-009
SPL v8
SPL
SPL Set ID 8efc9f4e-3b20-60ba-e053-2995a90af8b1
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
Cyclomethicone Water Levomenol Glycerin Isohexadecane Isopropyl Alcohol Povidone K90 Edetol Carbomer Interpolymer Type A (55000 Cps) Myristyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-07-31 Until 2023-04-30

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 usein or near the eyes or on mucous membranes.

In case of contact, rinse thoroughly with water.

Section 51945-4

BODE

Sterillium Comfort Gel

HEALTHCARE

PERSONNEL HAND RUB

85% v/v ethyl alcohol with moisturizers

Kills > 99.999% of germs

in 15 seconds without water.

Boosts skin moisture level.

Leaves hands feeling soft and healthy.

Dermatologically tested.

Read Drug Facts panel before use.

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC 65616-009-06

1000 mL 33.8 fl.oz. (1QT 1.8 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 usein or near the eyes or on mucous membranes.

In case of contact, rinse thoroughly with water.

Section 51945-4 (51945-4)

BODE

Sterillium Comfort Gel

HEALTHCARE

PERSONNEL HAND RUB

85% v/v ethyl alcohol with moisturizers

Kills > 99.999% of germs

in 15 seconds without water.

Boosts skin moisture level.

Leaves hands feeling soft and healthy.

Dermatologically tested.

Read Drug Facts panel before use.

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC 65616-009-06

1000 mL 33.8 fl.oz. (1QT 1.8 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 (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

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