NDC | 67618-153-01, 67618-153-03 |
Set ID | 0707b259-52a4-4ae6-b176-d093865906e7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Purdue Products LP |
Generic Name | |
Product Class | Antiseptic |
Product Number | |
Application Number | PART333A |
- Drug Facts
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BETADINE SOLUTION SWABSTICKS
povidone-iodine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-153 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE .01 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67618-153-01 1 in 1 PACKET 2 NDC:67618-153-03 3 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/15/1972 Labeler - Purdue Products LP (141916531) Registrant - Purdue Products LP (141916531) Establishment Name Address ID/FEI Business Operations Aplicare Inc. 107255002 MANUFACTURE