FIRST AID ONLY POVIDONE-IODINE PREP PAD- povidone-iodine patch 
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 Prep Pad

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

Label Image

FIRST AID ONLY POVIDONE-IODINE PREP PAD 
povidone-iodine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-8110(NDC:44019-811)
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
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-8110-001 in 1 POUCH07/26/2017
10.45 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/24/2017
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-8110) , repack(0924-8110)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(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
 
Acme United Corporation