Halodine Oral Antiseptic Spray

Drug Facts

Composition & Product

Active Ingredients

Iodine (1.25 g)

Inactive Ingredients

Hydroxyethyl Cellulose, Unspecified Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-10-01

Medication Information

Warnings and Precautions

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 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.

Indications and Usage

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

Purpose

Antiseptic

Dosage and Administration

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

1. Press down pump completely and spray twice into mouth. 2. Swish vigorously in mouth for 15 seconds. 3. Slightly lift chin and tilt head back to gargle. Spit out excess. Children under 3 years of age: Consult a dentist or doctor

Description

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

Section 42229-5

Povidone-Iodine USP, 1.25%

Helps Reduce Risk of Infection

4-Hour Formula

halodine.com

PATENT PENDING

Manufactured in the U.S.A.

for Halodine LLC 111 NE 1st St,

Ste 806, Miami, FL 33132

Section 44425-7

Other Information • Not made with natural rubber latex • Store at room temperature; avoid excessive heat

Section 50565-1

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

Section 51727-6

Inactive Ingredients hydroxyethylcellulose, purified water

Section 53413-1

Questions or comments? [email protected]

Packaging

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%

(0.125% Available Iodine)

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

1. Press down pump completely and spray twice into mouth. 2. Swish vigorously in mouth for 15 seconds. 3. Slightly lift chin and tilt head back to gargle. Spit out excess. Children under 3 years of age: Consult a dentist or doctor

Warnings and Precautions (34071-1)

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 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.

Section 42229-5 (42229-5)

Povidone-Iodine USP, 1.25%

Helps Reduce Risk of Infection

4-Hour Formula

halodine.com

PATENT PENDING

Manufactured in the U.S.A.

for Halodine LLC 111 NE 1st St,

Ste 806, Miami, FL 33132

Section 44425-7 (44425-7)

Other Information • Not made with natural rubber latex • Store at room temperature; avoid excessive heat

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients hydroxyethylcellulose, purified water

Section 53413-1 (53413-1)

Questions or comments? [email protected]

Purpose

Antiseptic

Packaging

Drug Facts

Active Ingredient

Povidone-Iodine USP, 1.25%

(0.125% Available Iodine)

Advanced Ingredient Data

[{"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "1.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses • Oral Antiseptic • First aid to help prevent infection in minor oral irritation caused by dental procedures", "34068-7": "Directions For oral antisepsis in adults and children 3 years of age and older: 1. Press down pump completely and spray twice into mouth. 2. Swish vigorously in mouth for 15 seconds. 3. Slightly lift chin and tilt head back to gargle. Spit out excess. Children under 3 years of age: Consult a dentist or doctor", "34071-1": "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 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.", "42229-5": "Povidone-Iodine USP, 1.25% Helps Reduce Risk of Infection 4-Hour Formula halodine.com PATENT PENDING Manufactured in the U.S.A. for Halodine LLC 111 NE 1st St, Ste 806, Miami, FL 33132", "44425-7": "Other Information • Not made with natural rubber latex • Store at room temperature; avoid excessive heat", "50565-1": "Keep out of reach of children. If large amounts swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive Ingredients hydroxyethylcellulose, purified water", "53413-1": "Questions or comments? contact@halodine.com", "Purpose": "Antiseptic", "Active Ingredient": "Povidone-Iodine USP, 1.25% (0.125% Available Iodine)"}

Halodine Oral Antiseptic Spray

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information