Label: BETADINE- povidone iodine liquid
- NDC Code(s): 0116-0181-08
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 7, 2024
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- Active Ingredient
- Purpose
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Warning
Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high
fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than
2 days or administer to 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 othe ringredients in this product
■ if you have any thyroid condtions
When using this product■ do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor
■ do not swallow
■ do not use with hydrogen peroxide
Stop use and ask a doctor■ 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. - INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BETADINE
povidone iodine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-0181 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 0.05 mg in 1 mL Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-0181-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/07/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 11/07/2024 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-0181)