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NDC 67618-0180-12 Betadine Cream 0.05 mg/mL Details

Betadine Cream 0.05 mg/mL

Betadine Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Avrio Health L.P.. The primary component is POVIDONE-IODINE.

Product Information

NDC	67618-0180
Product ID	67618-180_65f99e2a-698a-47f5-a14c-d97b33eb348e
Associated GPIs	92200040003705
GCN Sequence Number	007222
GCN Sequence Number Description	povidone-iodine CREAM (G) 5 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	47650
HICL Sequence Number	004265
HICL Sequence Number Description	POVIDONE-IODINE
Brand/Generic	Brand
Proprietary Name	Betadine Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	POVIDONE-IODINE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.05
Active Ingredient Units	mg/mL
Substance Name	POVIDONE-IODINE
Labeler Name	Avrio Health L.P.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 67618-0180-12 (67618018012)

Pricing Information	N/A
NDC Package Code	67618-180-12
Billing NDC	67618018012
Package	1 TUBE in 1 CARTON (67618-180-12) / 15 mL in 1 TUBE
Marketing Start Date	1980-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d4839bfa-4e7a-0431-a7b8-8a34360ae30a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

SPL UNCLASSIFIED SECTION

Purpose

First aid antiseptic

SPL UNCLASSIFIED SECTION

Uses

First aid to help prevent infection in minor

cuts
scrapes
burns

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Directions

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

SPL UNCLASSIFIED SECTION

Other information

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

SPL UNCLASSIFIED SECTION

Inactive ingredients

cetostearyl alcohol,glycerin, mineral oil, PEG-50 stearate, polysorbate 60, potassium iodate, sodium hydroxide, sorbitan monostearate, water, white petrolatum

Dist. by:

Avrio Health L.P.

Stamford, CT 06901-3431

305099-0B

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Betadine Cream

NDC: 67618-180-12

INGREDIENTS AND APPEARANCE

BETADINE CREAM

povidone-iodine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67618-180
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.05 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67618-180-12	1 in 1 CARTON	06/01/1980
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/1980

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Name	Address	ID/FEI	Business Operations
Establishment
Mundipharma Pharmaceuticals Limited		365982441	MANUFACTURE(67618-180)

Revised: 12/2021

Document Id: 65f99e2a-698a-47f5-a14c-d97b33eb348e

Set id: d4839bfa-4e7a-0431-a7b8-8a34360ae30a

Version: 3

Effective Time: 20211215

Search by Drug Name or NDC

NDC 67618-0180-12 Betadine Cream 0.05 mg/mL Details

Betadine Cream 0.05 mg/mL

Product Information

Package

Package Images

NDC 67618-0180-12 (67618018012)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d4839bfa-4e7a-0431-a7b8-8a34360ae30a Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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