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NDC 00924-8112-03 First Aid Only Povidone-Iodine Antiseptic 1 g/100mL Details

First Aid Only Povidone-Iodine Antiseptic 1 g/100mL

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

Product Information

NDC	00924-8112
Product ID	0924-8112_9b7f2580-0750-e1d3-e053-2995a90a2eef
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	SWAB
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100mL
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 00924-8112-03 (00924811203)

Pricing Information	N/A
NDC Package Code	0924-8112-03
Billing NDC	00924811203
Package	100 POUCH in 1 CARTON (0924-8112-03) / .5 mL in 1 POUCH
Marketing Start Date	2020-01-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9b7f2fc2-f201-2746-e053-2a95a90ac0d8 Details

Active Ingredient:

Povidone-Iodine Solution 10%

Purpose:

Antiseptic

Use:

First aid antiseptic to help prevent skin infection.

Warnings:

For external use only.

SPL UNCLASSIFIED SECTION

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

Directions:

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

INGREDIENTS AND APPEARANCE

FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC

povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-8112(NDC:65517-0034)
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
NONOXYNOL-10 (UNII: K7O76887AP)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-8112-01	10 in 1 CARTON	01/07/2020
1		0.5 mL in 1 POUCH; Type 0: Not a Combination Product
2	NDC:0924-8112-00	0.5 mL in 1 POUCH; Type 0: Not a Combination Product	01/07/2020
3	NDC:0924-8112-02	50 in 1 CARTON	01/07/2020
3		0.5 mL in 1 POUCH; Type 0: Not a Combination Product
4	NDC:0924-8112-03	100 in 1 CARTON	01/07/2020
4		0.5 mL 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 not final	part333E	01/07/2020

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-8112) , repack(0924-8112)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	relabel(0924-8112) , repack(0924-8112)

Revised: 1/2020

Document Id: 9b7f2580-0750-e1d3-e053-2995a90a2eef

Set id: 9b7f2fc2-f201-2746-e053-2a95a90ac0d8

Version: 1

Effective Time: 20200107