65616-011

65616-011
SPL v1
SPL
SPL Set ID 2bc46854-fe65-782b-e063-6294a90a79af
Route
topical
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (89.5 mL)
Inactive Ingredients
glycerin myristyl alcohol water isopropyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-15

Purpose

Antiseptic

Description

Ethyl Alcohol 85% w/w


Medication Information

Warnings

For external use only.

Flammable, keep away from fire or flame.

Uses

• surgical hand antiseptic

• significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Purpose

Antiseptic

Directions

• apply to clean, dry hands

• for the first use of the day, use a nail pick

• dispense approx. 2 mL into hand, dip fingers of opposite hand into palm, working product under nails and into cuticles

• repeat procedure with other hand

• with hands still moist spead around the hand and lower 1/3 of the forearm

• reapply the product to the hands, paying particular attention to fingers, cuticles, and interdigital spaces

• following application, rub hands until dry

• hands should remain moist for entire application time, approx. 1.5 minutes

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 50567-7

When using this product avoid contact with eyes. In case of contact with eyes, flush immediately with water.

Section 50570-1

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

Section 51945-4

Sterillium

rub

fragrance-free

PROCEDURAL RUB

Surgical hand rub

Fast-acting. Dermatologically tested.

Gentle to skin.

Hand Antiseptic Rub

85% w/w ethyl alcohol with moisturizers

Surgical hand antiseptic. Significantly reduces

the number of microorganisms on the hands

and forearms prior to surgery or patient care.

Read drug facts panel before use.

Designed in Germany. Made in USA.

Lot:

Use by:

BODE

NDC 65616-011-03

500 mL 16.91 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

• surgical hand antiseptic

• significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Purpose

Antiseptic

Directions

• apply to clean, dry hands

• for the first use of the day, use a nail pick

• dispense approx. 2 mL into hand, dip fingers of opposite hand into palm, working product under nails and into cuticles

• repeat procedure with other hand

• with hands still moist spead around the hand and lower 1/3 of the forearm

• reapply the product to the hands, paying particular attention to fingers, cuticles, and interdigital spaces

• following application, rub hands until dry

• hands should remain moist for entire application time, approx. 1.5 minutes

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 50567-7 (50567-7)

When using this product avoid contact with eyes. In case of contact with eyes, flush immediately with water.

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Sterillium

rub

fragrance-free

PROCEDURAL RUB

Surgical hand rub

Fast-acting. Dermatologically tested.

Gentle to skin.

Hand Antiseptic Rub

85% w/w ethyl alcohol with moisturizers

Surgical hand antiseptic. Significantly reduces

the number of microorganisms on the hands

and forearms prior to surgery or patient care.

Read drug facts panel before use.

Designed in Germany. Made in USA.

Lot:

Use by:

BODE

NDC 65616-011-03

500 mL 16.91 fl. oz

Active Ingredient (Active ingredient)

Ethyl Alcohol 85% w/w


Advanced Ingredient Data


Raw Label Data

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