Betadine® Sore Throat Gargle

Drug Facts

Composition & Product

Active Ingredients

Iodine (.05 mg)

Inactive Ingredients

Glycerin Propylene Glycol Water Saccharin Sodium Sodium Hydroxide Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-06-15

Medication Information

Purpose

Antiseptic

Description

Active ingredient Povidone-iodine, 0.5%(0.05% available iodine)

Uses

For the temporary relief of occasional sore throat

Section 42229-5

Dist. by: Avrio Health L.P.Stamford, CT 06901-3431

305586-0E

Section 50565-1

Keep out of reach of children. In case more than used for gargling is accidentally swallowed, getmedical help or contact a Poison Control Center right away.

Section 51945-4

BetadineGargle Carton

NDC: 67618-181-08

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

SoreThroat Warning: Severe or persistent sore throat or sore throataccompanied by high fever, headache, nausea, and vomiting may be serious.Consult doctor promptly. Do not use more than 2 days or administerto children under 3 years of age unless directed by a doctor.

Directions

DO NOT SWALLOW

Adults andchildren 12 years and older:

Gargle with 10 ml full strength for 30 seconds, then spitout
Use only with dosing cup provided
Use up to 4 times daily

Children under 12: Do not use.

Drug Facts

Active ingredient

Povidone-iodine, 0.5%(0.05% available iodine)

Other Information

store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C(59⁰-86⁰F)
may stain clothing or dental work
avoid contact with jewelry, especially silver

Inactive Ingredients

citric acid,flavor, glycerin, propylene glycol, purified water, saccharin sodium,sodium hydroxide

Do Not Use This Product

for more than 7 days unless directed by a dentist or doctor
if you are allergic to povidone-iodine or any other ingredientsin this product
if you have any thyroid conditions

When Using This Product

do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor
do not swallow
do not use with hydrogen peroxide

Stop Use and Ask A Doctor If

symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
swelling, rash, or fever develops

Structured Label Content

Uses

For the temporary relief of occasional sore throat

Section 42229-5 (42229-5)

Dist. by: Avrio Health L.P.Stamford, CT 06901-3431

305586-0E

Section 50565-1 (50565-1)

Keep out of reach of children. In case more than used for gargling is accidentally swallowed, getmedical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

BetadineGargle Carton

NDC: 67618-181-08

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antiseptic

Warnings

SoreThroat Warning: Severe or persistent sore throat or sore throataccompanied by high fever, headache, nausea, and vomiting may be serious.Consult doctor promptly. Do not use more than 2 days or administerto children under 3 years of age unless directed by a doctor.

Directions

DO NOT SWALLOW

Adults andchildren 12 years and older:

Gargle with 10 ml full strength for 30 seconds, then spitout
Use only with dosing cup provided
Use up to 4 times daily

Children under 12: Do not use.

Drug Facts

Active ingredient

Povidone-iodine, 0.5%(0.05% available iodine)

Other Information (Other information)

store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C(59⁰-86⁰F)
may stain clothing or dental work
avoid contact with jewelry, especially silver

Inactive Ingredients (Inactive ingredients)

citric acid,flavor, glycerin, propylene glycol, purified water, saccharin sodium,sodium hydroxide

Do Not Use This Product (Do not use this product)

for more than 7 days unless directed by a dentist or doctor
if you are allergic to povidone-iodine or any other ingredientsin this product
if you have any thyroid conditions

When Using This Product (When using this product)

do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor
do not swallow
do not use with hydrogen peroxide

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
swelling, rash, or fever develops

Advanced Ingredient Data

[{"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": ".05", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of occasional sore throat", "42229-5": "Dist. by: Avrio Health L.P.Stamford, CT 06901-3431 305586-0E", "50565-1": "Keep out of reach of children. In case more than used for gargling is accidentally swallowed, getmedical help or contact a Poison Control Center right away.", "51945-4": "BetadineGargle Carton NDC: 67618-181-08", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antiseptic", "Warnings": "SoreThroat Warning: Severe or persistent sore throat or sore throataccompanied by high fever, headache, nausea, and vomiting may be serious.Consult doctor promptly. Do not use more than 2 days or administerto children under 3 years of age unless directed by a doctor.", "Directions": "DO NOT SWALLOW Adults andchildren 12 years and older: Gargle with 10 ml full strength for 30 seconds, then spitout Use only with dosing cup provided Use up to 4 times daily Children under 12: Do not use.", "Drug Facts": "Active ingredient Povidone-iodine, 0.5%(0.05% available iodine)", "Other information": "store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C(59⁰-86⁰F) may stain clothing or dental work avoid contact with jewelry, especially silver", "Inactive ingredients": "citric acid,flavor, glycerin, propylene glycol, purified water, saccharin sodium,sodium hydroxide", "Do not use this product": "for more than 7 days unless directed by a dentist or doctor if you are allergic to povidone-iodine or any other ingredientsin this product if you have any thyroid conditions", "When using this product": "do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor do not swallow do not use with hydrogen peroxide", "Stop use and ask a doctor if": "symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops"}