Halodine Nasal Antiseptic

Halodine Nasal Antiseptic
SPL v3
SPL
SPL Set ID a9dd7e56-1a97-5f0b-e053-2995a90a43bf
Route
TOPICAL
Published
Effective Date 2020-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1.25 mg)
Inactive Ingredients
Hydroxyethyl Cellulose, Unspecified Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-15

Description

Povidone-Iodine USP, 1.25% (0.125% Available Iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine USP, 1.25% (0.125% Available Iodine)

Uses
  • Antiseptic skin preparation
  • Helps reduce bacteria that can potentially cause skin infection
Section 42229-5

HELPS REDUCE RISK OF INFECTION •  4-HOUR FORMULA

Non-sterile Solution

Manufactured in the U.S.A. for Halodine LLC

111 NE 1st St, Ste 806, Miami, FL 33132

halodine.com

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Packaging

Directions

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.

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%



(0.125% Available Iodine)

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?

Structured Label Content

Uses
  • Antiseptic skin preparation
  • Helps reduce bacteria that can potentially cause skin infection
Section 42229-5 (42229-5)

HELPS REDUCE RISK OF INFECTION •  4-HOUR FORMULA

Non-sterile Solution

Manufactured in the U.S.A. for Halodine LLC

111 NE 1st St, Ste 806, Miami, FL 33132

halodine.com

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic

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.

Packaging

Directions

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.

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%



(0.125% Available Iodine)

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? (Questions or comments?)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)