Label: BETADINE- povidone-iodine spray
- NDC Code(s): 67618-148-03
- Packager: Purdue Products LP
- 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 January 31, 2011
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- Drug Facts
Povidone-iodine, 5% (0.5% available iodine).Close
Patient pre-operative skin preparation
- for preparation of the skin prior to surgery
- helps reduce bacteria that potentially can cause skin infection
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.
- hold container about 4-6 inches from skin
- spray desired area n allow to dry
- may be bandaged
- replace cap after use
- Other information
- store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F). Do not freeze.
- Inactive ingredients
citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified waterClose
- SPL UNCLASSIFIED SECTION
Dist. by: Purdue Products L.P., Stamford, CT 06901-3431Close
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
Product 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