BETADINE GARGLE- povidone-iodine solution 
Atlantis Consumer Healthcare, Inc.

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BETADINE® Sore Throat Gargle
0.5% Povidone-iodine

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

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:

Children under 12: Do not use.

Other information

Inactive ingredients

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

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

BetadineGargle Carton
NDC: 67618-181-08

Betadine Gargle Carton
BETADINE GARGLE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-181
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE.05 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-181-081 in 1 CARTON06/15/2020
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02206/15/2020
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
Registrant - Atlantis Consumer Healthcare, Inc. (118983925)

Revised: 12/2023
Document Id: 7b70e574-3038-4b4f-ace5-36ebe3baa070
Set id: 5f0a3377-1398-2603-c632-f0d214bb88ec
Version: 7
Effective Time: 20231222
 
Atlantis Consumer Healthcare, Inc.