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FDA LABEL GENERIC: Chlorhexidine MFR: Professional Disposables International, Inc.

Chlorhexidine Gluconate 3.15 % / Isopropyl Alcohol 70 % Medicated Pad

Active ingredients

Chlorhexidine gluconate 3.15% w/v

Isopropyl alcohol 70% v/v

Purposes

Antiseptic

Antiseptic

Use

for the preparation of the patient's skin prior to surgery or injection

Warnings

For external use only

Flammable, k eep away from fire or flame

To reduce the risk of fire, PREP CAREFULLY:

solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area

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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

on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser under occlusive patch

When using this product

keep out of eyes, ears, mouth and mucous membranes. May cause serious or permanent injury if permitted to enter and remain.

If contact occurs, rinse with cold water right away and contact a doctor.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. maximum treatment area for one swabstick is approximately 8.4 in. x 8.4 in. (21.3 cm by 21.3 cm). tear open the pouch to expose the swabstick remove swabstick from package. Do not touch the foam tip. prior to surgery or injection, apply one flat side of foam tip to the proposed skin site and prep the skin in vigorous back-and-forth repeated strokes, turning the swabstick over (unused side of the foam tip) halfway in the procedure dry site: scrub repeatedly back and forth for 15 seconds with each side of the applicator for a total of 30 seconds. Allow to air dry for approximately 30 seconds. moist site: scrub repeatedly for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes. if using an ignition source, allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). do not blot or wipe away discard after a single use

Other information

store between 68-77°F (20-25°C) avoid freezing and excessive heat above 104°F (40°C) for hospital and professional use only

Inactive ingredients

USP purified water

Package/Label Principal Display Panel

Prevantics(R) Maxi Swabstick
[Chlorhexidine Gluconate (3.15%)*
and Isopropyl Alcohol (70%) Swab]

Patient preoperative skin preparation
Non-sterile solution

Packaging is sterile when in sterile kit

*equivalent to 161 mg of Chlorhexidine Gluconate per pouch

For External Use Only Use for the preparation of the patient's skin prior to surgery or injection Helps reduce bacteria that potentially can cause skin infection For hospital and professional use only Latex free

IMPORTANT: See carton for complete Drug Facts and safety information.

Packet Label

Box Label

Packet (bulk):

Insert: