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NDC 00904-1102-31 Major Povidone Iodine 100 mg/g Details

Major Povidone Iodine 100 mg/g

Major Povidone Iodine is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is POVIDONE-IODINE.

Product Information

NDC	00904-1102
Product ID	0904-1102_931d28a6-d1d1-49f0-b58b-53492e35d817
Associated GPIs	92200040004210
GCN Sequence Number	007225
GCN Sequence Number Description	povidone-iodine OINT. (G) 10 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	29761
HICL Sequence Number	004265
HICL Sequence Number Description	POVIDONE-IODINE
Brand/Generic	Generic
Proprietary Name	Major Povidone Iodine
Proprietary Name Suffix	n/a
Non-Proprietary Name	POVIDONE-IODINE
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/g
Substance Name	POVIDONE-IODINE
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-1102-31 (00904110231)

Pricing Information	N/A
NDC Package Code	0904-1102-31
Billing NDC	00904110231
Package	1 TUBE in 1 CARTON (0904-1102-31) / 28.35 g in 1 TUBE
Marketing Start Date	2006-08-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bf631ed8-1080-4586-ae54-57b93d0eb158 Details

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient

Povidone Iodine USP10% w/w (available iodine 1%)

Purpose

Antiseptic-germicidal

Uses

for the treatment of:

minor wounds
infections
kills bacteria promptly

Warnings

For external use only.

Do not use

over large areas of the body
if you are allergic to any of the ingredients
longer than 1 week unless directed by a doctor

When using this product

Avoid contact with eyes.

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

redness, irritation or swelling occurs or pain persists

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

apply directly to affected area
may be bandaged

Other information

Store at controlled room temperature 15°-30°C (59°-86°F).
Close cap tightly after use.
For control no. and expiration date, see carton and/or crimp of tube.
Will not stain natural fabrics.
Protect from freezing.

Inactive ingredients

glycerin, PEG-6, PEG-32, propylene glycol

Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, Ml 48150 USA

Re-Oder No. 100433 M-101

Principal Display Panel – 1 oz. Tube

Major® NDC 0904-1102-31

Povidine™

FIRST AID OINTMENT

NET WT. 1 OZ (28.35 g) *Compare to

POVIDINE – IODINE 10% Active Ingredient of

AVAILABLE IODINE 1% Betadine® Ointment

Principal Display Panel – 1 oz. Carton

Major® NDC 0904-1102-31

Povidine™ *Compare to

FIRST AID OINTMENT Active Ingredient of

NET WT. 1OZ (28.35 g) POVIDINE - IODINE 10% Betadine® Ointment

INGREDIENTS AND APPEARANCE

MAJOR POVIDONE IODINE

povidone-iodine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-1102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-1102-31	1 in 1 CARTON	08/14/2006
1		28.35 g 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 final	part333C	08/14/2006

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2021

Document Id: 931d28a6-d1d1-49f0-b58b-53492e35d817

Set id: bf631ed8-1080-4586-ae54-57b93d0eb158

Version: 3

Effective Time: 20210113