Active Ingredients
Povidone-Iodine 8.3% w/w
Isopropyl alcohol 72.5% w/w
The following Structured Product Label (SPL) was submitted to the FDA by Xinxiang Xinda Technology Co.,ltd for the product Swab Applicator Brushes 8.3% W/w Povidone-iodine And 72.5% W/w Isopropyl Alcohol (ipa) (NDC 84128-009). 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, purposes, use, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Povidone-Iodine 8.3% w/w
Isopropyl alcohol 72.5% w/w
Antiseptic
for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
For external use only.
Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY:
Do not use 3-ml applicator for head and neck surgery
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
On patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
For lumbar puncture or in contact with the meninges
On open skin wounds or as a general skin cleanser
keep out of eyes, ears, and mouth. 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.
if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
If swallowed, get medical help or contact a Poison Control Center right away.
Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Use in a well ventilated area
Maximal treatment area for one applicator is approximately 4 in. x 5 in. (129 cm²).
Do not use 3-ml applicator for head and neck surgery
Remove applicator from package; do not touch sponge hold the applicator with the sponge down. Open the switch only once to activate the ampules and release the antiseptic.
Wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
Completely wet the treatment area with antiseptic
Dry surgical sites(e.g. abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds
Moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes
Do not allow solution to pool; tuck prep towels to absorb solution, and then remove
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 the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.
Store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C(104°F)
Purified water
* Please review the disclaimer below.