BETADINE- povidone-iodine swab 
Purdue Products LP

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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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 carton
BETADINE 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-152-01100 in 1 CARTON04/01/199204/30/2019
10.01 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/199204/30/2019
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Inc081054904MANUFACTURE(67618-152)

Revised: 6/2022
Document Id: ab0c08ce-edef-4cc6-980b-02d125e6e065
Set id: d032d0f7-3cdc-29d9-7320-188113b08e30
Version: 3
Effective Time: 20220628
 
Purdue Products LP