NDC | 67618-148-03 |
Set ID | 2f07daa4-86ee-4a2d-ae3a-c3a7b574ed10 |
Category | HUMAN OTC DRUG LABEL |
Packager | Purdue Products LP |
Generic Name | |
Product Class | Antiseptic |
Product Number | |
Application Number | PART333A |
- Drug Facts
- Purpose
Antiseptic
Uses
Patient pre-operative skin preparation
- for preparation of the skin prior to surgery
- helps reduce bacteria that potentially can cause skin infection
- Warnings
For external use only
Do not use
- in the eyes
- If you are allergic to povidone-iodine or any other ingredients in this preparation
When using this product
- prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
- in pre-operative prepping, avoid “pooling” beneath the patient
Stop use and ask a doctor if
- irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Directions
- hold container about 4-6 inches from skin
- spray desired area n allow to dry
- may be bandaged
- replace cap after use
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
BETADINE
povidone-iodine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-148 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE .05 mL in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) GLYCERIN (UNII: PDC6A3C0OX) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67618-148-03 89 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/15/1992 Labeler - Purdue Products LP (141916531) Establishment Name Address ID/FEI Business Operations Thatcher Company 041307356 MANUFACTURE