Label: POVIDONE IODINE - povidone iodine swab
- NDC Code(s): 49953-1893-1
- Packager: Dalian Rongbang Medical Healthy Devices Co
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 2, 2010
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- ACTIVE INGREDIENT
Saturated with: 10% povidone-Iodine, 1% Titratable IodineClose
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
1 Swabstick. Apply to procedure site as needed.Close
- INDICATIONS & USAGE
For professional and hospital use
Apply to procedure site as needed. discard after single use.Close
For professional and hospital use.
For external use only.
Discard after single use.
If pain, irritation, redness or swelling occurs, discontinue use and consult a physician.Close
- KEEP OUT OF REACH OF CHILDREN
Professional and Hosptial use.
Apply to procedure site as needed.
- PRINCIPAL DISPLAY PANEL
Povidone-Iodine Swabstick (1's)Saturated with: 10% povidone-Iodine, 1% titratable iodine.
- INGREDIENTS AND APPEARANCE
povidone iodine swab
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49953-1893 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 10 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49953-1893-1 1 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/02/2010 Labeler - Dalian Rongbang Medical Healthy Devices Co (529882730) Registrant - Dalian Rongbang Medical Healthy Devices Co (529882730) Establishment Name Address ID/FEI Business Operations Dalian Rongbang Medical Healthy Devices Co 529882730 manufacture