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Betadine by Purdue Products LP

Medically reviewed on September 25, 2017

Dosage form: swab
Ingredients: POVIDONE-IODINE 100mg in 1mL
Labeler: Purdue Products LP
NDC Code: 67618-152

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.

BETADINE® Solution Swab Aid®
Povidone-iodine Solution USP, 10% (equal to 1% available iodine)

Drug Facts Not for Retail Sale – For Professional and Hospital Use Only

Active ingredient

Povidone-iodine Solution USP, 10% (equal to 1% available iodine)

Purpose

Antiseptic

Uses
  • for preparation of skin prior to surgery
  • helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only

Do not use this product

  • in the eyes
  • if you are allergic to iodine or other product ingredients

When using this product
  • prolonged exposure may cause irritation or, rarely, severe skin reactions

Stop using this product
  • if irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.
  • in rare instances of local irritation or sensitivity

Keep out of reach of children.

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

Directions
  • tear slit; pull top of packette up and away, exposing pad
  • use pad to swab area thoroughly
  • repeat using the other side if necessary
  • use one time only. Each packette contains 1 Swab Aid Antiseptic pad.

Other information
  • store between 20°-25°C (68°-77°F). Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients citric acid, disodium phosphate, nonoxynol-9, purified water, sodium hydroxide

©2013, Purdue Products L.P.

Dist by: Purdue Products L.P.
Stamford, CT 06901-3431
300983-0D

Betadine Solution Swab Aid Antiseptic Pads - Carton
NDC 67618-152-01

BETADINE 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-152
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
NONOXYNOL-9 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:67618-152-01100 PACKET in 1 CARTON
10.01 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/1992
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIOperations
Aplicare Inc107255002MANUFACTURE(67618-152)

 
Purdue Products LP

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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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