FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC- povidone-iodine patch 
Acme United Corporation

----------

First Aid Only Povidone-Iodine Antiseptic Pad

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

Pouch label Pouch Label

FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC 
povidone-iodine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-8113(NDC:59050-455)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-10 (UNII: K7O76887AP)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-8113-005.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/03/2022
2NDC:0924-8113-0110 in 1 CARTON06/03/2022
25.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0924-8113-0250 in 1 CARTON06/03/2022
35.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:0924-8113-03100 in 1 CARTON08/19/2024
45.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00306/03/2022
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-8113) , repack(0924-8113)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-8113) , repack(0924-8113)

Revised: 8/2024
Document Id: 1f93db77-6db7-9866-e063-6394a90aa068
Set id: e0052ac2-4f74-32a4-e053-2995a90a94c6
Version: 2
Effective Time: 20240813
 
Acme United Corporation