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Full Care Povidone Iodine Swabsticks

Dosage form: swab
Ingredients: POVIDONE-IODINE 0.2g
Labeler: Shaoxing Fuqing Health Products Co., Ltd.
NDC Code: 65028-001

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%)

Purpose: Antiseptic

Use: Antiseptic skin preparation

Warnings:

Do not use

  • if allergic to iodine
  • in the eyes

For external use only

Avoid "pooling" beneath patients.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

Stop use and ask a doctor if

  • redness, irritation, swelling, or pain persists or increases
  • infection occurs

Apply locally as need

Other information

  • For hospital or professional use only

Inactive Ingredient

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

FULL CARE POVIDONE IODINE SWABSTICKS 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65028-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE0.2 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CITRIC ACID MONOHYDRATE 
SODIUM HYDROXIDE 
GLYCERIN 
NONOXYNOL-10 
Packaging
#Item CodePackage Description
1NDC:65028-001-013 SWAB in 1 POUCH
2NDC:65028-001-021 SWAB in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/22/2014
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(65028-001)

Revised: 09/2014
 
Shaoxing Fuqing Health Products 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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