POVIDONE-IODINE PREP PAD MEDIUM STERILE- povidone-iodine pad cloth 
Zhejiang Xingheng Medical Supplies Co., Ltd.

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.

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81636-006 Povidone-Iodine Pad

Povidone-lodine 10% w/w (equivalent to iodine 1%)

Antiseptic

For external use only.

● Clean the affected area
● Apply product on the area 1-3times daily and discard
● May be covered with a sterile bandage when dry

Do not use:

Stop use and consult a doctor

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

If swallowed, get medical help or contact Poison Control Center right away.

Sodium Bicarbonate, Polysorbate 20, Polyethylene Glycol 400, Potassium Iodate, Water

Apply topically as needed to cleanse intendend area;

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.

Use for preparation of skin prior to injection,apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be 1min.Please clean before disinfection.

Povidone-Iodine Pad 81636-006-01

POVIDONE-IODINE PREP PAD MEDIUM STERILE 
povidone-iodine pad cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81636-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 0.01 g  in 100 g
POTASSIUM IODATE (UNII: I139E44NHL) 0.01 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.01 g  in 100 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.01 g  in 100 g
WATER (UNII: 059QF0KO0R) 89.96 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81636-006-01100 in 1 CARTON08/16/2022
1100 in 1 BOX
15.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/16/2022
Labeler - Zhejiang Xingheng Medical Supplies Co., Ltd. (554554581)
Registrant - Zhejiang Xingheng Medical Supplies Co., Ltd. (554554581)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Xingheng Medical Supplies Co., Ltd.554554581manufacture(81636-006)

Revised: 8/2022
Document Id: e6666508-818c-10f8-e053-2995a90a530f
Set id: e6666508-818b-10f8-e053-2995a90a530f
Version: 1
Effective Time: 20220816
 
Zhejiang Xingheng Medical Supplies Co., Ltd.