Sterillium Rub Fragrance Free Ndc 65616-008

Sterillium Rub Fragrance Free Ndc 65616-008
SPL v6
SPL
SPL Set ID 8e73359b-af12-955c-e053-2a95a90a76b6
Route
TOPICAL
Published
Effective Date 2023-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (89.5 mL)
Inactive Ingredients
Water Isopropyl Alcohol Myristyl Alcohol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-31

Description

Ethyl Alcohol 85% w/w

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 85% w/w

Uses
  • surgical hand antiseptic
  • significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
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 productavoid contact with eyes. In case of contact with eyes, flush immediately with water.

Section 50570-1

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

Section 51945-4

BODE

Sterillium Rub

Fragrance-Free

Procedural Rub

SURGICAL HAND RUB

85% w/w ethyl alcohol with emollients

Indication: Significantly reduces the number

of micro-organisms on the hands and forearms

prior to surgery or patient care.

Fast-actng. Dermatologically tested.

Gentle to skin.

Read Drug Facts panel before use.

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC 65616-008-06

1000 mL 33.8 fl.oz.

Warnings

For external use only.

Flammable, keep away from fire or flame.

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 spread 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.
Active Ingredient

Ethyl Alcohol 85% w/w

Inactive Ingredients

glycerin, isopropyl alcohol,myristyl alcohol, water


Structured Label Content

Uses
  • surgical hand antiseptic
  • significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care
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 productavoid contact with eyes. In case of contact with eyes, flush immediately with water.

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

BODE

Sterillium Rub

Fragrance-Free

Procedural Rub

SURGICAL HAND RUB

85% w/w ethyl alcohol with emollients

Indication: Significantly reduces the number

of micro-organisms on the hands and forearms

prior to surgery or patient care.

Fast-actng. Dermatologically tested.

Gentle to skin.

Read Drug Facts panel before use.

Lot:

Use by:

Questions? Call 1-800-MEDLINE

NDC 65616-008-06

1000 mL 33.8 fl.oz.

Purpose

Antiseptic

Warnings

For external use only.

Flammable, keep away from fire or flame.

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 spread 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.
Active Ingredient (Active ingredient)

Ethyl Alcohol 85% w/w

Inactive Ingredients (Inactive ingredients)

glycerin, isopropyl alcohol,myristyl alcohol, water


Advanced Ingredient Data


Raw Label Data

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