Povidone-Iodine Pad

Dosage form: swab
Ingredients: POVIDONE-IODINE 9.43g in 100g
Labeler: Shandong Haiyan Medical Manufacture Co., Ltd.
NDC Code: 42339-002

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.

Antiseptic Povidone-Iodine Prep Pad 10% Povidone-Iodine, 1% available Iodine. SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD. www. haiyan-medical.com

Active Ingredient Povidone Iodine 10% w/w (equivalent to iodine 1%)

Purpose Antiseptic

Use Antiseptic for preparation of the skin.

WarningsFor external use only.

Discontinue use if irritation and redness develop.

Keep out of reach of Children.

Directions
Apply locally as needed.
Other Information
Store at room temperature: 59°- 86°F(15 - 30℃)

Inactive ingredientsPurified Water

POVIDONE-IODINE PAD 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42339-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE9.43 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:42339-002-0110 BOX (BOX) in 1 CONTAINER
1100 POUCH (POUCH) in 1 BOX
10.6 g in 1 POUCH
2NDC:42339-002-02100 BOX (BOX) in 1 CONTAINER
2100 POUCH (POUCH) in 1 BOX
20.6 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/18/2012
Labeler - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)
Establishment
NameAddressID/FEIOperations
Shandong Haiyan Medical Manufacture Co., Ltd. 421283439manufacture

Revised: 03/2012
 
Shandong Haiyan Medical Manufacture Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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