84128-014

Manufacturer: XINXIANG XINDA TECHNOLOGY CO.,LTD | Xinxiang Xinda Technology Co., Ltd.
Effective date: 2026-06-23
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: monthly-update
Hydrated at: 2026-07-17 21:35:30

Label at a glance#

ProductSwab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)

Active ingredientPOVIDONE-IODINE, ISOPROPYL ALCOHOL

Label structure13 sections

Dosage and administration

Storage and handling

Store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C(104°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Iodine (0.7% Available Iodine)

Isopropyl alcohol 74% w/w

Purposes

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

On patients with known allergies to Iodine or isopropyl alcohol
For lumbar puncture or in contact with the meninges
On open skin wounds or as a general skin cleanser

When using this product

OTC - WHEN USING SECTION

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.

Stop use and ask a doctor

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Use with care in premature infants or infants under 2 months of age. These products may cause skin irritation or chemical burns.
Use in a well ventilated area
Maximal treatment area for one applicator is approximately 13.2 in. x 13.2 in. (1126 cm²). Do not use 26-ml applicator for area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.
Do not use 26-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.

Other information

STORAGE AND HANDLING SECTION

Store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C(104°F)