Active Ingredients
Chlorhexidine gluconate 3.15% w/v
Isopropyl alcohol 70% v/v
Prevantics Swab Solution
FDA Label NDC 10819-1080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Professional Disposables International, Inc. for the product Prevantics Swab (NDC 10819-1080). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Packet (Packet)
Box Label
Box (Box)
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