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Betadine by Purdue Products LP

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Purdue Products LP
NDC Code: 67618-150

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

10% Povidone-iodine

Drug Facts

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Purpose

First aid antiseptic

Uses

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Warnings For external use only

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to povidone-iodine or any other ingredients in this preparation

Ask a doctor before use if you have

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop use and ask a doctor if

  • the condition persists or gets worse
  • you need to use this product for more than 1 week

Keep out of reach of children.

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

Directions

  • clean the affected area
  • apply a small amount of product to the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

  • store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)

Inactive ingredients

pareth 25-9, purified water, sodium hydroxide

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

303993-0B

©2015, Purdue Products L.P.


Betadine Solution
NDC: 67618-150-08

BETADINE  SOLUTION
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-150
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
C12-15 PARETH-9 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:67618-150-0514.8 mL in 1 BOTTLE
2NDC:67618-150-04118 mL in 1 BOTTLE
3NDC:67618-150-08237 mL in 1 BOTTLE
4NDC:67618-150-09237 mL in 1 BOTTLE
5NDC:67618-150-16473 mL in 1 BOTTLE
6NDC:67618-150-17473 mL in 1 BOTTLE
7NDC:67618-150-32946 mL in 1 BOTTLE
8NDC:67618-150-013780 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/1980
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIOperations
Thatcher Company041307356MANUFACTURE(67618-150)

Revised: 01/2016
 
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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