Label: BETADINE ANTISEPTIC ORAL RINSE- povidone-iodine solution
- NDC Code(s): 67618-182-08
- 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 February 9, 2021
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- Drug Facts
Do not use this product
- for more than 7 days unless directed by a dentist or doctor
- in children under 12 years of age 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
- Use full strength
- Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out.
- Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out.
- With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BETADINE ANTISEPTIC ORAL RINSE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-182 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:67618-182-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/08/2021 Labeler - Avrio Health L.P. (141916531) Registrant - Purdue Pharma L.P. (932323652) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 MANUFACTURE(67618-182)