POVIDONE IODINE PREP PADS- povidone iodine prep pads cloth 
Custom Kits Company Inc

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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Povidone Iodine Prep Pad

Drug Facts

Active Ingredient

Povidone Iodine 10%

Purpose

Antiseptic

Uses

Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes and burns.

For preparation of the skin prior to surgery

Helps reduct bacteria that can potentially cause skin infection

Warnings

For External Use Only

Do Not Use

In the eyes

As a first aid antiseptic for more than 1 week

Over large areas of the body

Ask doctor before use if you have

Deep or puncuture wounds

Animal bites

Serious wounds

Stop Use and ask doctor if

Condition worsens or persists for more than 72 hours

Irritation and rednes develops

Keep Out of the reach of Children

If swallowed, get medical help or contact a Poson Control Center immediately

Directions

Tear at notch

Remove applicator

Use only once

As a first aid antiseptic - Clean affected area

apply 1 to 3 times daily

May be covered with a sterile bandage

If bandaged let dry first

Store at room temperature

Avoid excessive heat

Inactive ingredient

nonoxynol-9, water

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POVIDONE IODINE PREP PADS 
povidone iodine prep pads cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68183-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68183-119-0110 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product10/21/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/21/2015
Labeler - Custom Kits Company Inc (928643712)
Establishment
NameAddressID/FEIBusiness Operations
Dynarex812771980manufacture(68183-119)
Establishment
NameAddressID/FEIBusiness Operations
Custom Kits Company Inc928643712relabel(68183-119) , repack(68183-119)

Revised: 1/2020
Document Id: 7e02f6ee-8e03-6aa2-e053-2991aa0a8d97
Set id: 222a1db3-d4b2-58ee-e054-00144ff8d46c
Version: 3
Effective Time: 20200117
 
Custom Kits Company Inc