Label: BETADINE GARGLE- povidone-iodine solution
- NDC Code(s): 67618-181-08
- Packager: Avrio Health L.P.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated October 23, 2020
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- Drug Facts
Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult 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 other ingredients in this product
- if you have any thyroid conditions
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
- PREGNANCY OR BREAST FEEDING
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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 not final part356 06/15/2020 Labeler - Avrio Health L.P. (141916531) Registrant - Purdue Pharma LP (932323652) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 MANUFACTURE(67618-181)