BETADINE GARGLE- povidone-iodine solution

Betadine Gargle by

Drug Labeling and Warnings

Betadine Gargle by is a Otc medication manufactured, distributed, or labeled by Avrio Health L.P., Purdue Pharma LP, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

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

Purpose

Antiseptic

Uses

• For the temporary relief of occasional sore throat

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.

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

PREGNANCY OR BREAST FEEDING

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

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.

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.

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

SPL UNCLASSIFIED SECTION

Dist. by: Avrio Health L.P.Stamford, CT 06901-3431
305586-0E

PRINCIPAL DISPLAY PANEL

BetadineGargle Carton
NDC: 67618-181-08

INGREDIENTS AND APPEARANCE

BETADINE GARGLE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-181
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	.05 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-181-08	1 in 1 CARTON	06/15/2020
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	06/15/2020

Labeler - Atlantis Consumer Healthcare, Inc. (118983925)

Registrant - Atlantis Consumer Healthcare, Inc. (118983925)