FDA Label for Prevantics Swab
View Indications, Usage & Precautions
Prevantics Swab 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
Purpose
Antiseptic
Antiseptic
Use
for the preparation of the patient's skin prior to an injection
Warnings
- For external use only
- Flammable, keep away from fire or flame
- Do not use with electrocautery procedures
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 swab is approximately 2.5 by 2.5 inches (6 by 6 cm)
- tear open packet and remove swab. Do not unfold swab.
- prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. Apply swab to skin using repeated back-and-forth strokes for 15 seconds.
- allow the prepped area to air dry for 30 seconds
- 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
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
Package/Label Principal Display Panel
Reorder No. B10800
NDC 10819-1080-1
Prevantics
(R) Swab
[Chlorhexidine Gluconate (3.15%) and Isopropyl Alcohol (70%) Swab]
Antiseptic
Non-sterile solution
- For external use only
- Single step, broad spectrum, persistent antiseptic that significantly reduces the number of microorganisms on intact skin
- Use for the preparation of the patient's skin prior to an injection
- Helps reduce bacteria that potentially can cause skin infection
- Latex free
- For hospital and professional use only
IMPORTANT: See carton for complete Drug Facts and safety information.
Packet Label
Box Label
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