BETADINE CREAM- povidone-iodine cream 
Atlantis Consumer Healthcare Inc.

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® Cream

5% Povidone-iodine

Drug Facts

Active ingredient
Povidone-iodine, 5% (0.5% available iodine)

Purpose
First aid antiseptic

Uses
First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Warnings For externaluse only

Do not use

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

Ask a doctor beforeuse if you have

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop use and aska 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, getmedical help or contact a Poison Control Center right away

Directions

  • clean the affected area
  • apply a small amount of product (equal to the surface areaof a fingertip) to the area 1 to 3 times daily
  • may be covered with a sterile bandage

Other information

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

Inactive ingredients
cetostearyl alcohol,glycerin, mineral oil, PEG-50stearate, polysorbate 60, potassium iodate, sodium hydroxide, sorbitanmonostearate, water, white petrolatum

Dist. by:
Avrio HealthL.P.
Stamford, CT 06901-3431

305099-0B

BetadineCream
NDC: 67618-180-12

Betadine-Cream-Carton
BETADINE CREAM 
povidone-iodine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.05 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
cetostearyl alcohol (UNII: 2DMT128M1S)  
glycerin (UNII: PDC6A3C0OX)  
mineral oil (UNII: T5L8T28FGP)  
PEG-50 stearate (UNII: 776CJK5X56)  
polysorbate 60 (UNII: CAL22UVI4M)  
potassium iodate (UNII: I139E44NHL)  
sodium hydroxide (UNII: 55X04QC32I)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
water (UNII: 059QF0KO0R)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-180-121 in 1 CARTON06/01/198012/31/2023
115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/198012/31/2023
Labeler - Atlantis Consumer Healthcare Inc. (118983925)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Mundipharma Pharmaceuticals Limited365982441MANUFACTURE(67618-180)

Revised: 8/2023
Document Id: a8b5be70-d3d0-4858-80fd-e73f58072cac
Set id: d4839bfa-4e7a-0431-a7b8-8a34360ae30a
Version: 6
Effective Time: 20230801
 
Atlantis Consumer Healthcare Inc.