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NDC 42339-0003-02 Povidone-Iodine Pad 9.43 g/100g Details

Povidone-Iodine Pad 9.43 g/100g

Povidone-Iodine Pad is a TOPICAL SWAB in the HUMAN OTC DRUG category. It is labeled and distributed by Shandong Haiyan Medical Manufacture Co., Ltd.. The primary component is POVIDONE-IODINE.

Product Information

NDC	42339-0003
Product ID	42339-003_c9185c17-2603-99e8-e053-2a95a90af9fb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Povidone-Iodine Pad
Proprietary Name Suffix	n/a
Non-Proprietary Name	Povidone-Iodine
Product Type	HUMAN OTC DRUG
Dosage Form	SWAB
Route	TOPICAL
Active Ingredient Strength	9.43
Active Ingredient Units	g/100g
Substance Name	POVIDONE-IODINE
Labeler Name	Shandong Haiyan Medical Manufacture Co., Ltd.
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 42339-0003-02 (42339000302)

Pricing Information	N/A
NDC Package Code	42339-003-02
Billing NDC	42339000302
Package	100 BOX in 1 CONTAINER (42339-003-02) / 100 POUCH in 1 BOX / .6 g in 1 POUCH
Marketing Start Date	2012-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c9187a07-92d5-15ac-e053-2995a90af4cb Details

Active Ingredient

Povidone Iodine 10% w/w (equivalent to iodine 1%)

Purpose

Antiseptic

Use

Antiseptic for preparation of the skin.

Warnings

For external use only.

Discontinue use if irritation and redness develop.

Keep out of reach of Children.

Directions

Apply locally as needed.

Other Information

Store at room temperature: 59°- 86°F(15 - 30℃)

Inactive ingredients

Purified Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PAD

povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42339-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	9.43 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42339-003-01	10 in 1 CONTAINER	02/18/2012
1		100 in 1 BOX
1		0.6 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:42339-003-02	100 in 1 CONTAINER	02/18/2012
2		100 in 1 BOX
2		0.6 g in 1 POUCH; 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	02/18/2012

Labeler - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)

Name	Address	ID/FEI	Business Operations
Establishment
Shandong Haiyan Medical Manufacture Co., Ltd.		421283439	manufacture(42339-003)

Revised: 8/2021

Document Id: c9185c17-2603-99e8-e053-2a95a90af9fb

Set id: c9187a07-92d5-15ac-e053-2995a90af4cb

Version: 3

Effective Time: 20210809