FDA.reportPublic FDA data

Betadine Cream

Manufacturer
Atlantis Consumer Healthcare Inc. | Purdue Pharma LP | Mundipharma Pharmaceuticals Limited
Effective date
2023-08-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:27:48

Label at a glance#

ProductBetadine Cream
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

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

OTC - PURPOSE SECTION

Purpose
First aid antiseptic

INDICATIONS & USAGE SECTION

Uses
First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, getmedical help or contact a Poison Control Center right away

OTC - WHEN USING SECTION

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

HOW SUPPLIED SECTION

Other information

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

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

OTC - STOP USE SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BetadineCream
NDC: 67618-180-12

Betadine-Cream-Carton
Betadine-Cream-Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-180-12GM - Gram67618-180f676e81b-1d22-4938-9d6b-4d98b67fe23b12021-03-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-18067618-180-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
cetostearyl alcohol2DMT128M1SIACT
glycerinPDC6A3C0OXIACT
mineral oilT5L8T28FGPIACT
PEG-50 stearate776CJK5X56IACT
polysorbate 60CAL22UVI4MIACT
potassium iodateI139E44NHLIACT
sodium hydroxide55X04QC32IIACT
sorbitan monostearateNVZ4I0H58XIACT
water059QF0KO0RIACT
petrolatum4T6H12BN9UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a8b5be70-d3d0-4858-80fd-e73f58072cacd4839bfa-4e7a-0431-a7b8-8a34360ae30a2023-08-01WarningsExact identifier
spl id: a8b5be70-d3d0-4858-80fd-e73f58072cac
spl set id: d4839bfa-4e7a-0431-a7b8-8a34360ae30a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.