84128-002

84128-002
SPL v2
SPL
SPL Set ID 125a49c3-15c0-fbad-e063-6394a90a5d2e
Route
CUTANEOUS
Published
Effective Date 2024-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 g)
Inactive Ingredients
Sodium Laureth-5 Sulfate Glycerin Water Hydroxyethyl Cellulose, Unspecified Polydextrose

Identifiers & Packaging

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

Description

10%Povidone-iodine (minimumavailable iodine 1.0%) W/W

Purpose

Surgical Hand Scrub


Medication Information

Purpose

Surgical Hand Scrub

Description

10%Povidone-iodine (minimumavailable iodine 1.0%) W/W

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 01b

Active Ingredient

10%Povidone-iodine

(minimumavailable iodine 1.0%) W/W

Other Information

● Store at 20-25° (68-77°F).

● Avoid overheating 40°C (104 F)

● Discard after one-time use.

Inactive Ingredients

Alkyl Polyglycoside, Sodium Alcohol Ether Sulphate, Hydroxyethylcellulose, Glycerol, 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 01b (REF 2502-01B)

Active Ingredient (Active ingredient)

10%Povidone-iodine

(minimumavailable iodine 1.0%) W/W

Other Information (Other information)

● Store at 20-25° (68-77°F).

● Avoid overheating 40°C (104 F)

● Discard after one-time use.

Inactive Ingredients (Inactive ingredients)

Alkyl Polyglycoside, Sodium Alcohol Ether Sulphate, Hydroxyethylcellulose, Glycerol, 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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