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Full Care Povidone Iodine Solution

Dosage form: solution
Ingredients: POVIDONE-IODINE 1g in 100mL
Labeler: Shaoxing Fuqing Health Products Co., Ltd.
NDC Code: 65028-006

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.

Active Ingredient: Povidone-Iodine USP 10% (1.0% Available Iodine)

Purpose: Antiseptic

Use: Prepping Intact Skin and Mucous Membranes Prior to Surgery

Warnings:

For external use only

Avoid use on persons allergic to iodine

Keep out of reach of children. If swallowed, get medical help or consult a poison control center right away

Stop use and ask a doctor if

  • Skin shows symptoms of irritation, sensitivity, redness, pain, or swelling.

Directions: Patient Preoperative Prep:

Use full strength. Apply solution to preoperative site following povidone iodine scrub application. Use a circular motion,start as incision site and move onward. Remove all soiled underdrapes. Do not allow solution to pool.

Other information

  • Store at room temperature.
  • Avoid excessive heat (above 104F/40C)
  • Protect from freezing)
  • Laetx free

Inactive Ingredient

Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water

FULL CARE POVIDONE IODINE SOLUTION 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65028-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CITRIC ACID MONOHYDRATE 
SODIUM HYDROXIDE 
GLYCERIN 
NONOXYNOL-10 
Packaging
#Item CodePackage Description
1NDC:65028-006-0159 mL in 1 BOTTLE
2NDC:65028-006-0288.5 mL in 1 BOTTLE
3NDC:65028-006-03109 mL in 1 BOTTLE
4NDC:65028-006-0450 mL in 1 BOTTLE
5NDC:65028-006-05100 mL in 1 BOTTLE
6NDC:65028-006-06150 mL in 1 BOTTLE
7NDC:65028-006-07200 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/22/2014
Labeler - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
Establishment
NameAddressID/FEIOperations
Shaoxing Fuqing Health Products Co., Ltd.530545003manufacture(65028-006)

 
Shaoxing Fuqing Health Products Co., Ltd.

Medically reviewed on Oct 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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