FDA Label for Prevantics Swabstick
View Indications, Usage & Precautions
Prevantics Swabstick Product Label
The following document was submitted to the FDA by the labeler of this product Professional Disposables International, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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, keep away from fire or flame
- Do not use with electrocautery procedures
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 maxi swabstick is approximately: dry site: 4 by 4 inches (10 by 10 cm) or moist site: 3 by 5 inches (7.5 by 12.5 cm)
- tear open the pouch to expose the swabstick
- remove the 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) half way 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 back and forth for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes.
- do not blot or wipe dry
- 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
Packet Label
Box Label
Packet (bulk)
Insert
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