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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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First Aid Only Povidone-Iodine Antiseptic Pads

Active Ingredient:

Povidone-Iodine Solution 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 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

Carton Label Image

FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-8112(NDC:65517-0034)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-8112-0110 in 1 CARTON01/07/2020
10.5 mL in 1 POUCH; Type 0: Not a Combination Product
2NDC:0924-8112-000.5 mL in 1 POUCH; Type 0: Not a Combination Product01/07/2020
3NDC:0924-8112-0250 in 1 CARTON01/07/2020
30.5 mL in 1 POUCH; Type 0: Not a Combination Product
4NDC:0924-8112-03100 in 1 CARTON01/07/2020
40.5 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/07/2020
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-8112) , repack(0924-8112)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(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
 
Acme United Corporation