Your browser does not support JavaScript! GOOD CARE POVIDONE IODINE SWABSTICKS (POVIDONE-IODINE) SWAB [DALIAN GOODWOOD MEDICAL CARE LTD.]
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GOOD CARE POVIDONE IODINE SWABSTICKS (povidone-iodine) swab
[Dalian Goodwood Medical Care Ltd.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Good Care Povidone Iodine, USP Swabsticks


Active Ingredient

Povidone Iodine USP, 10%

Purpose

Antiseptic

Uses

  • 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

Warnings

  • For external use only. 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.

Consult a doctor in case of deep or puncture wounds, animal bites, serious burns.

Stop use and consult a doctor if the condition persists or gets worse.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control right away

Directions

For preparation of the skin prior to surgery clean the affected area, remove swab by 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.

Other Information

  • Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

Inactive Ingredients

Purified water, Povidone Iodine, Citric Acid Disodium Hydrogen Phosphate Dodecahydrate Potassium Iodate Nonoxynol

Manufactured by Dalian Goodwood Medical Care Ltd.

Made in China

Good Care Povidone Iodine, USP Swabsticks (1s) (50 pouches/box) (50685-009-01)


PovidoneIodine1s

PovidoneIodine1s50pouchesbox

Good Care Povidone Iodine, USP Swabsticks (2s) (25 pouches/box) (50685-009-02)


PovidoneIodine2s

PovidoneIodine2s25pouchesbox

Good Care Povidone Iodine, USP Swabsticks (3s) (25 pouches/box) (50685-009-03)


PovidoneIodine3s

PovidoneIodine3s25pouchesbox

GOOD CARE POVIDONE IODINE SWABSTICKS  
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50685-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 
POTASSIUM IODATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50685-009-0150 in 1 BOX
10.7 g in 1 PACKET
2NDC:50685-009-0225 in 1 BOX
21.4 g in 1 PACKET
3NDC:50685-009-0325 in 1 BOX
32.1 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E02/13/2013
Labeler - Dalian Goodwood Medical Care Ltd. (529575699)
Registrant - Dalian Goodwood Medical Care Ltd. (529575699)
Establishment
NameAddressID/FEIBusiness Operations
Dalian Goodwood Medical Care Ltd.529575699manufacture(50685-009)

Revised: 2/2013
 
Dalian Goodwood Medical Care Ltd.

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