Label: BETADINE GARGLE- povidone-iodine solution
- NDC Code(s): 67618-181-08
- Packager: Atlantis Consumer Healthcare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 22, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Purpose
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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
- PREGNANCY OR BREAST FEEDING
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BETADINE GARGLE
povidone-iodine solutionProduct 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)