HALODINE NASAL ANTISEPTIC SWABSTICK- povidone-iodine solution

Halodine Nasal Antiseptic Swabstick by

Drug Labeling and Warnings

Halodine Nasal Antiseptic Swabstick by is a Otc medication manufactured, distributed, or labeled by Halodine LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Povidone-Iodine USP, 2.5%

(0.25% Available Iodine)

Purpose

Antiseptic

Uses

• Antiseptic skin preparation
• Helps reduce bacteria that can potentially cause skin infection

Warnings

For external use only.

Do not use

• If allergic to iodine
• In the eyes
• On children less than 3 years old
• Over large areas of the body

Ask a doctor before use if injuries are

• Deep or puncture wounds
• Serious burns

Stop use and ask a doctor if

irritation and redness develop or if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

For nasal application

1. Gently blow nose to clear both nostrils. Discard tissue.
2. Open swabstick. Hold tube between thumb and forefinger at blue band with handle up. With other hand, hold handle at base, and bend to snap open. Bend and snap in opposite direction to disconnect swabstick. Remove swabstick from tube.
3. Apply medication. Insert swabstick comfortably into right nostril. Do not insert swab more than 1/4” past nasal opening. Rotate swab within nostril for a total of 15 seconds, using a gentle swirling motion. Discard tube and swabstick.
4. Repeat steps 2 and 3 with second swabstick for left nostril.

Note: Do not blow nose. If solution drips, wipe with tissue.

Other Information

• Single use only; do not reuse
• Not made with natural rubber latex
• Store at room temperature; avoid excessive heat

Inactive Ingredients

hydroxyethylcellulose, purified water

Questions or comments?

contact@halodine.com

Packaging

INGREDIENTS AND APPEARANCE

HALODINE NASAL ANTISEPTIC SWABSTICK 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78371-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78371-301-01	100 in 1 CARTON	07/24/2020
1		0.5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 78371-301-02	6 in 1 BOX	10/06/2020
2		0.5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
3	NDC: 78371-301-12	20 in 1 CARTON	10/06/2020
3		6 in 1 BOX
3		0.5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/24/2020

Labeler - Halodine LLC (117526113)