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NDC 00924-8110-00 First Aid Only Povidone-Iodine Prep Pad 10 g/100g Details

First Aid Only Povidone-Iodine Prep Pad 10 g/100g

First Aid Only Povidone-Iodine Prep Pad is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Acme United Corporation. The primary component is POVIDONE-IODINE.

Product Information

NDC	00924-8110
Product ID	0924-8110_509b6c8e-6aa0-2656-e054-00144ff8d46c
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	First Aid Only Povidone-Iodine Prep Pad
Proprietary Name Suffix	n/a
Non-Proprietary Name	Povidone-Iodine
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	g/100g
Substance Name	POVIDONE-IODINE
Labeler Name	Acme United Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00924-8110-00 (00924811000)

Pricing Information	N/A
NDC Package Code	0924-8110-00
Billing NDC	00924811000
Package	1 PATCH in 1 POUCH (0924-8110-00) / .45 g in 1 PATCH
Marketing Start Date	2017-07-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 509b6c8e-6a9f-2656-e054-00144ff8d46c Details

Active Ingredients

Active Ingredients Povidone Iodine 10%

Purpose

Purpose Antiseptic

Use

Use Antispetic for preparation of the skin.

Warnings

Warnings •For external use only.

•Discontinue use if irritation and redness develop.

•Keep out of reach of children.

Keep out of reach of children

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

Directions

Directions Apply locally as needed.

Other Information

Other Information Store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredient

Inactive Ingredient purified water

Package Principal Display Panel

INGREDIENTS AND APPEARANCE

FIRST AID ONLY POVIDONE-IODINE PREP PAD

povidone-iodine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-8110(NDC:44019-811)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-8110-00	1 in 1 POUCH	07/26/2017
1		0.45 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/24/2017

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-8110) , repack(0924-8110)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	relabel(0924-8110) , repack(0924-8110)

Revised: 7/2017

Document Id: 509b6c8e-6aa0-2656-e054-00144ff8d46c

Set id: 509b6c8e-6a9f-2656-e054-00144ff8d46c

Version: 1

Effective Time: 20170724