SWAB APPLICATOR BRUSHES 8.3% W/W POVIDONE-IODINE AND 72.5% W/W ISOPROPYL ALCOHOL (IPA)- povidone-iodine, isopropyl alcohol swab

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients

Povidone-Iodine 8.3% w/w

Isopropyl alcohol 72.5% w/w

Purposes

Antiseptic

Use

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

Warnings

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

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

When using this product

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

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.
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.

Other information

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

Inactive ingredients

Purified water

84128-009-03

84128-009-06

84128-009-10

84128-009-26

84128-009-30

84128-009-35

INGREDIENTS AND APPEARANCE

SWAB APPLICATOR BRUSHES 8.3% W/W POVIDONE-IODINE AND 72.5% W/W ISOPROPYL ALCOHOL (IPA) 
povidone-iodine, isopropyl alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84128-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	83 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	725 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84128-009-03	20 in 1 BOX	05/13/2026
1		1 in 1 BAG
1		3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 84128-009-06	20 in 1 BOX	05/13/2026
2		1 in 1 BAG
2		6 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 84128-009-10	10 in 1 BOX	05/13/2026
3		1 in 1 BAG
3		10.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
4	NDC: 84128-009-26	10 in 1 BOX	05/13/2026
4		1 in 1 BAG
4		26 mL in 1 APPLICATOR; Type 0: Not a Combination Product
5	NDC: 84128-009-30	10 in 1 BOX	05/13/2026
5		1 in 1 BAG
5		30 mL in 1 APPLICATOR; Type 0: Not a Combination Product
6	NDC: 84128-009-35	10 in 1 BOX	05/13/2026
6		1 in 1 BAG
6		35 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	05/13/2026

Labeler - XINXIANG XINDA TECHNOLOGY CO.,LTD (546423962)

Establishment
Name	Address	ID/FEI	Business Operations
Xinxiang Xinda Technology Co., Ltd.		546423962	manufacture(84128-009)