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NDC 00924-8113-02 First Aid Only Povidone-Iodine Antiseptic 10 g/100g Details

First Aid Only Povidone-Iodine Antiseptic 10 g/100g

First Aid Only Povidone-Iodine Antiseptic 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	00924-8113
Product ID	0924-8113_e0052c81-0896-9409-e053-2a95a90ae9b3
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 Antiseptic
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	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00924-8113-02 (00924811302)

Pricing Information	N/A
NDC Package Code	0924-8113-02
Billing NDC	00924811302
Package	50 POUCH in 1 CARTON (0924-8113-02) / 5.5 g in 1 POUCH
Marketing Start Date	2022-06-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e0052ac2-4f74-32a4-e053-2995a90a94c6 Details

Drug Facts

Active ingredient

Povidone-lodine 10%

Purpose

Antiseptic

Use

First aid antiseptic to help prevent skin infection

Warnings

For external use only

Do not use

▪ in eyes ▪ over large areas of the body ▪ if allergic to any of the ingredients

▪ longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

▪ deep or puncture wounds ▪ animal bites ▪ serious burns

Stop use and ask a doctor if

▪ conditions worsen or clear up and then recur

▪ the condition persists for more than 7 days

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Driections

Open packet and wipe affected area. Apply 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other information

Store at room temperature.

Inactive ingredients:

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide,

purified water, sodium hydroxide

PRINCIPAL DISPLAY PANEL

Pouch label

INGREDIENTS AND APPEARANCE

FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC

povidone-iodine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-8113(NDC:59050-455)
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
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
NONOXYNOL-10 (UNII: K7O76887AP)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-8113-00	5.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	06/03/2022
2	NDC:0924-8113-01	10 in 1 CARTON	06/03/2022
2		5.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC:0924-8113-02	50 in 1 CARTON	06/03/2022
3		5.5 g in 1 POUCH; 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	part333E	06/03/2022

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-8113) , repack(0924-8113)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	relabel(0924-8113) , repack(0924-8113)

Revised: 5/2022

Document Id: e0052c81-0896-9409-e053-2a95a90ae9b3

Set id: e0052ac2-4f74-32a4-e053-2995a90a94c6

Version: 1

Effective Time: 20220531