Pre-scrub Ii Surgical Hand Scrub

Pre-scrub Ii Surgical Hand Scrub
SPL v3
SPL
SPL Set ID 1a2028e1-4c3c-4c94-b0a4-7eb6e273f60e
Route
TOPICAL
Published
Effective Date 2012-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (1 mg)
Inactive Ingredients
Coco Diethanolamide Gluconolactone Isopropyl Alcohol Lauramine Oxide Polyethylene Glycol 3350 Lanolin Water Tridecyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Active Since 1989-03-01

Description

Active Ingredient Chlorhexidine gluconate 4% Solution


Medication Information

Warnings and Precautions

Warnings

For external use only

____________________________________________________________________

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

____________________________________________________________________

Do not use

  • If you are allergic to chlorhexidine gluconate or any other ingredient in this

product

____________________________________________________________________

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury

if permitted to enter or allowed to remain.

  • if contact occurs, rinse with cold water right away
  • do not use routinely if you have wounds which involve more thank the superficial

layers of the skin

____________________________________________________________________

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs.

These may be signs of a serious condition.

Indications and Usage

Uses

surgical hand scrub: significantly reduces the number of micro-

organisms on the hands and forearms prior to surgery or patient care

Dosage and Administration

Directions

• Use with care in Premature infants under 2 months of age. These

products may cause irritation or chemical burns.

• open package

• wet hands and forearms to the elbows with warm water

• clean under nails with nail pick provided. Nails should be maintained

with a 1 millimeter free edge

• wet sponge and squeeze to work up lather

• scrub thoroughly for 3 minutes. Paying particular attention to the

nails, cuticles and interdigital spaces. Use the brush side to clean the

nails, cuticles and interdigital spaces between the fingers and the

sponge side to scrub the hands and forearms

• rinse thoroughly with warm water

• scrub for an additional 3 minutes using the sponge side

• discard brush-sponge

• rinse hands and forearms thoroughly and dry with a sterile towel.

Description

Active Ingredient Chlorhexidine gluconate 4% Solution

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients cocamide DEA, fragrance POFL 147, glucono-delta-lactone, isopropyl alcohol 4%, lauramine oxide, PEG-75 lanolin, purified water, USP, tridecyl alcohol

Section 51945-4

Section 53413-1

Questions? 800-424-5556 (Monday to Friday 8 AM – 5 PM)

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Chlorhexidine gluconate 4% Solution

Section 60561-8

Other information

• store between 20-25ºC (68-77ºF)

•avoid freezing and excessive heat 40ºC (104ºF}


Structured Label Content

Indications and Usage (34067-9)

Uses

surgical hand scrub: significantly reduces the number of micro-

organisms on the hands and forearms prior to surgery or patient care

Dosage and Administration (34068-7)

Directions

• Use with care in Premature infants under 2 months of age. These

products may cause irritation or chemical burns.

• open package

• wet hands and forearms to the elbows with warm water

• clean under nails with nail pick provided. Nails should be maintained

with a 1 millimeter free edge

• wet sponge and squeeze to work up lather

• scrub thoroughly for 3 minutes. Paying particular attention to the

nails, cuticles and interdigital spaces. Use the brush side to clean the

nails, cuticles and interdigital spaces between the fingers and the

sponge side to scrub the hands and forearms

• rinse thoroughly with warm water

• scrub for an additional 3 minutes using the sponge side

• discard brush-sponge

• rinse hands and forearms thoroughly and dry with a sterile towel.

Warnings and Precautions (34071-1)

Warnings

For external use only

____________________________________________________________________

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

____________________________________________________________________

Do not use

  • If you are allergic to chlorhexidine gluconate or any other ingredient in this

product

____________________________________________________________________

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury

if permitted to enter or allowed to remain.

  • if contact occurs, rinse with cold water right away
  • do not use routinely if you have wounds which involve more thank the superficial

layers of the skin

____________________________________________________________________

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs.

These may be signs of a serious condition.

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 51727-6 (51727-6)

Inactive ingredients cocamide DEA, fragrance POFL 147, glucono-delta-lactone, isopropyl alcohol 4%, lauramine oxide, PEG-75 lanolin, purified water, USP, tridecyl alcohol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 800-424-5556 (Monday to Friday 8 AM – 5 PM)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Chlorhexidine gluconate 4% Solution

Section 60561-8 (60561-8)

Other information

• store between 20-25ºC (68-77ºF)

•avoid freezing and excessive heat 40ºC (104ºF}


Advanced Ingredient Data


Raw Label Data

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