Label: GOOD CARE POVIDONE IODINE PAD - povidone-iodine swab
- NDC Code(s): 50685-007-01
- Packager: Dalian Goodwood Medical Care Ltd.
- 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 March 28, 2011
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- ACTIVE INGREDIENT
Povidone Iodine USP, 10% w/v
(equivalent to 1% titratable iodine)Close
- INDICATIONS & USAGE
- Health-care antiseptic for preparation of the skin prior to surgery
For external use only.Close
- DO NOT USE
Do not use or apply in the eyes
- on individuals who are allergic or sensitive to iodine
- over large areas of the body
- as a first aid antiseptic
- animal bites
- serious burns
- STOP USE
Stop use and consult a doctor if the condition persists or gets worse.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Close
- DOSAGE & ADMINISTRATION
For preparation of the skin prior to surgery clean the affected area, remove swab by the stick, apply to the operative site prior to surgery.
- STORAGE AND HANDLING
Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)Close
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.
Made in China www.dl-goodwood.comClose
- PRINCIPAL DISPLAY PANEL
Povidone Iodine pad
10% povidone iodine
For Disinfection Use
- INGREDIENTS AND APPEARANCE
GOOD CARE POVIDONE IODINE PAD
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50685-007 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 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50685-007-01 0.4 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/23/2011 Labeler - Dalian Goodwood Medical Care Ltd. (529575699) Registrant - Dalian Goodwood Medical Care Ltd. (529575699) Establishment Name Address ID/FEI Business Operations Dalian Goodwood Medical Care Ltd. 529575699 manufacture