Label: HALODINE NASAL ANTISEPTIC- povidone-iodine solution
- NDC Code(s): 78371-101-01, 78371-101-03
- Packager: Halodine LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 13, 2020
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- Drug Facts
- Active Ingredient
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.
For nasal application
- Gently blow nose to clear both nostrils. Discard tissue.
- Open single ampoule by folding the narrow end along line. To avoid spill while opening, maintain ampoule with narrow end pointing up.
- Place narrow end of ampoule at right nostril and gently pinch left nostril. Lift chin and tilt head back; squeeze all liquid from ampoule while inhaling through right nostril. Discard ampoule.
- Open second ampoule by folding the narrow end along line. Avoid spill.
- Place narrow end of ampoule at left nostril and gently pinch right nostril. Lift chin and tilt head back; squeeze all liquid from ampoule while inhaling through left nostril. Discard ampoule.
Note: Do not blow nose. If solution drips, wipe with tissue.
- Other Information
- Inactive Ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
HALODINE NASAL ANTISEPTIC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78371-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 1.25 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:78371-101-03 12 in 1 CARTON 10/28/2020 1 1.5 mL in 1 AMPULE; Type 0: Not a Combination Product 2 NDC:78371-101-01 96 in 1 CARTON 05/15/2020 2 1.5 mL in 1 AMPULE; 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 05/15/2020 Labeler - Halodine LLC (117526113)