Halodine Oral Rinse

Halodine Oral Rinse
SPL v3
SPL
SPL Set ID a9ee4c33-4a5b-3a1f-e053-2995a90aa515
Route
TOPICAL
Published
Effective Date 2020-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1.75 mg)
Inactive Ingredients
Water Hydroxyethyl Cellulose, Unspecified

Identifiers & Packaging

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

Description

Povidone-Iodine USP, 1.75% (0.175% Available Iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine USP, 1.75% (0.175% Available Iodine)

Uses
  • Oral Antiseptic
  • First aid to help prevent infection in minor oral irritation caused by dental procedures
Section 42229-5

Helps Reduce Risk of Infection

4-Hour Formula

Non-Sterile Antiseptic Solution

PATENT PENDING

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 •  For more than 7 days unless directed by a dentist or doctor

When using this product: Do not swallow

Stop use and promptly ask your dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

Packaging

Directions

For oral antisepsis in adults and children 3 years of age and older:

  • Twist off the narrow end of single ampoule.
  • Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.
  • Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.
  • Slightly lift chin and tilt head back to gargle, then spit out.

Children under 3 years of age: Consult a dentist or doctor

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.75%



(0.175% 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
  • Oral Antiseptic
  • First aid to help prevent infection in minor oral irritation caused by dental procedures
Section 42229-5 (42229-5)

Helps Reduce Risk of Infection

4-Hour Formula

Non-Sterile Antiseptic Solution

PATENT PENDING

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 •  For more than 7 days unless directed by a dentist or doctor

When using this product: Do not swallow

Stop use and promptly ask your dentist or doctor if sore mouth symptoms do not improve within 7 days, if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops.

Packaging

Directions

For oral antisepsis in adults and children 3 years of age and older:

  • Twist off the narrow end of single ampoule.
  • Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.
  • Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.
  • Slightly lift chin and tilt head back to gargle, then spit out.

Children under 3 years of age: Consult a dentist or doctor

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.75%



(0.175% 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

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