SANIISWAB AI- ethyl alcohol, povidone iodine swab

SaniiSwab by

Drug Labeling and Warnings

SaniiSwab by is a Otc medication manufactured, distributed, or labeled by POLLEY MED LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 62%. Purpose: Antiseptic

Povidone Iodine 10%. Purpose: Antiseptic

PURPOSE

Antiseptic

INDICATIONS & USAGE

Two-step method to clean and sanitize the skin of the inner nostrils

• Cleans with alcohol
• Sanitizes with povidone iodine

WARNINGS

Flammable, keep away from fire and flames

For external use only

DO NOT USE

Do Not Use:

• In eyes or mouth
• If product is opened or damaged
• If you are allergic to iodine or to any ingredients

Stop use and ask a doctor if redness, pain, or irritation appear and lasts more than 72 hours. Keep out of reach of children.

DOSAGE & ADMINISTRATION

For adults and children 12 years of age and older only

To be administered by medical personnel

Step 1. Cleaning. Open Step 1 packet and hold handle, inserting one swab tip into each nostril. Swab lower interior lining inside the nose in a circular motion for 30 seconds. Handle guard protects against insertion of swab tip beyond the nostrils. Discard.

Step 2. Sanitizing. Repeat Step 1 with Step 2 packet. Discard.

STORAGE AND HANDLING

• Protect from excessive moisture
• Avoid freezing and excessive heat above 40 °C (104 °F)
• Store at room temperature 20-25 °C (68-77 °F)

INACTIVE INGREDIENT

Water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANIISWAB  AI
ethyl alcohol, povidone iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84456-493
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.1 g  in 1 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 g  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84456-493-02	100 in 1 BOX	10/17/2024
1	NDC: 84456-493-01	0.25 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/17/2024

Labeler - POLLEY MED LLC (125097794)