Label: GOOD CARE POVIDONE IODINE- povidone-iodine swab
- NDC Code(s): 50685-001-01, 50685-001-03
- 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 December 27, 2018
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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
- First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
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 longer than 1 week unless directed by a doctor
- Discontinue use if irritation and redness develop.
- 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.
For use as a first aid antiseptic clean the affected area, apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.Close
- STORAGE AND HANDLING
Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)Close
- INACTIVE INGREDIENT
citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxideClose
- SPL UNCLASSIFIED SECTION
Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.
3-91 Jiulicun Yongzheng Street Jinzhou District Dalian China 116100
Made in China www.dl-goodwood.comClose
- PRINCIPAL DISPLAY PANEL
Povidone Iodine, USP Swabsticks
- Topical pre-surgical and first aid antiseptic swabstick
- For hospital and professional use only
- INGREDIENTS AND APPEARANCE
GOOD CARE POVIDONE IODINE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50685-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50685-001-01 2 mL in 1 POUCH; Type 0: Not a Combination Product 10/01/2010 2 NDC:50685-001-03 5.5 mL in 1 POUCH; Type 0: Not a Combination Product 10/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/01/2010 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(50685-001)