84128-003

84128-003
SPL v2
SPL
SPL Set ID 125ac9df-03db-83e9-e063-6394a90afeab
Route
CUTANEOUS
Published
Effective Date 2024-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Water Hydroxyethyl Cellulose, Unspecified Coco Diethanolamide Isopropyl Alcohol Lauramine Oxide Polydextrose Gluconolactone Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-27

Description

Chlorhexidine Gluconate Solution,4%

Purpose

Surgical Hand Scrub


Medication Information

Purpose

Surgical Hand Scrub

Description

Chlorhexidine Gluconate Solution,4%

Use

Preoperative cleaning of healthcare personnel arms and hands.Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery.

Warnings

For external use only.

Directions

●Wet hands, wrists and forearms to the elbows with water. Hands should be held higher than the elbows at all times

●Clean under nails with nail pick provided

●Use the brush side toclean the nails, cuticles and interdigital spaces between the fingersand the sponge side to scrub the hands and forearms. Wet sponge and squeeze to work up lather ·

●Scrub the nails, cuticles and interdigital spaces between the fingers, hands and forearms for 3 minutes in total . Scrub for an additional 2 minutes with using the sponge side only

●Rinse the hands, wrists and forearms with plenty of water

●Dry with a sterile towel from hands to elbows.Hold hands upwards.

Do Not Use

if redness or irritation occurs.

Ref 2502 01a

Active Ingredient

Chlorhexidine Gluconate Solution,4%

Other Information

● Store at 20-25° (68-77°F).

● Avoid overheating 40°C (104 F)

● Discard after single use.

Inactive Ingredients

Cocamide DEA, Fragrance POFL147, Glucono-deltalactone, Hydroxyethylcellulose, Iso-Propyl alcohol, Lauramine oxide, Glycerol, Alkyl Polyglycoside, Purified Water

When Using This Product

avoid contact with eyes.

Stop Use and Ask A Doctor If

severe adverse reactions occur.

Keep Out of Reach of Children.

If swallowed or gets in eyes,get medical help or contact a Poison Control Center immediately.


Structured Label Content

Use

Preoperative cleaning of healthcare personnel arms and hands.Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery.

Purpose

Surgical Hand Scrub

Warnings

For external use only.

Directions

●Wet hands, wrists and forearms to the elbows with water. Hands should be held higher than the elbows at all times

●Clean under nails with nail pick provided

●Use the brush side toclean the nails, cuticles and interdigital spaces between the fingersand the sponge side to scrub the hands and forearms. Wet sponge and squeeze to work up lather ·

●Scrub the nails, cuticles and interdigital spaces between the fingers, hands and forearms for 3 minutes in total . Scrub for an additional 2 minutes with using the sponge side only

●Rinse the hands, wrists and forearms with plenty of water

●Dry with a sterile towel from hands to elbows.Hold hands upwards.

Do Not Use (Do not use)

if redness or irritation occurs.

Ref 2502 01a (REF 2502-01A)

Active Ingredient (Active ingredient)

Chlorhexidine Gluconate Solution,4%

Other Information (Other information)

● Store at 20-25° (68-77°F).

● Avoid overheating 40°C (104 F)

● Discard after single use.

Inactive Ingredients (Inactive ingredients)

Cocamide DEA, Fragrance POFL147, Glucono-deltalactone, Hydroxyethylcellulose, Iso-Propyl alcohol, Lauramine oxide, Glycerol, Alkyl Polyglycoside, Purified Water

When Using This Product (When using this product)

avoid contact with eyes.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

severe adverse reactions occur.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed or gets in eyes,get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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