PROVODINE- providone iodine emulsion 
Microdermis 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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Provodine

Active ingredient

Povidone-iodine 7.5%

Purpose

Antiseptic

Uses

Patient Preoperative Skin Preparation: for preparation of the skin prior to a procedure. Helps reduce bacteria that potentially can cause skin infection.

Surgical Hand Scrub: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.

Healthcare Personnel Handwash: for handwashing to decrease bacteria on the skin after assisting ill persons.

Warnings

For external use only

Do not use in the eyes

Stop use and ask a doctor if

irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Surgical Hand Scrub:

■ Clean under nails with a nail pick.

■ Nails should be maintained with a 1 millimeter free edge.

■ Wet hands and forearms. ■ Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.

■ Scrub thoroughly for 60 seconds, paying particular attention to the nails, cuticles, and interdigital spaces.

■ Rinse and repeat scrub. ■ Dry with a clean towel.

Patient Preoperative Skin Preparation:

■ Clean the area.

■ Apply product to the operative site prior to surgery.

■ 1 mL (dime size) covers an estimated 5”x5” area.

■ Let dry 1-2 minutes.

Healthcare Personnel Handwash Without Water:

■ Place a smaller amount (3 mLs) of product in onehand.

■ Spread over both hands to wrist and rub into

the skin until dry (approximately 30 seconds).

Healthcare Personnel Handwash With Water:

■ Wet clean hands and wrists.

■ Apply 3 milliliters into one hand and spread over both hands to wrist.

■ Rub thoroughly for 30 seconds.

■ Let dry for 30 seconds.

■ Rinse for 30 seconds.

■ Dry with a clean towel.

Other Information

Store in a cool dry place, between 20°-25° C (66°-77° F)

Avoid freezing and excessive heat above 40° C (104° F)

Inactive Ingredients

Allantoin, Beeswax, Benzalkonium Chloride, Butylene, Glycol, C13-14 Isoparaffin, Caprylic/Capric, Triglyceride, Cetyl Alcohol, Disodium EDTA, Distearyl, Dimonium Chloride, Emulsifying Wax, NF, Glyceryl, Laurate, Glyceryl Stearate, Hydrogenated Jojoba Esters, Laureth-7, Nonoxynol-9, Octoxynol-9, PCA, PEG-100 Stearate, Polyacrylamide, Polyglyceryl-3 Diisostearate, Polyquaternium-7, Purified Water, Sclerotium Gum, Stearic Acid, Triethanolamine.

Questions?

Call (877) 710-6958 www.microdermis.com

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PROVODINE 
providone iodine emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59426-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
GLYCERYL LAURATE (UNII: Y98611C087)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-7 (UNII: Z95S6G8201)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
PIDOLIC ACID (UNII: SZB83O1W42)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
WATER (UNII: 059QF0KO0R)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59426-001-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59426-001-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59426-001-03100 in 1 BOX
33 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/15/2014
Labeler - Microdermis Corporation (969967988)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc061595175MANUFACTURE(59426-001)
Establishment
NameAddressID/FEIBusiness Operations
ACUPAC PACKAGING INC037138013manufacture(59426-001)

Revised: 7/2015
Document Id: e771a266-8743-4a45-87e3-ea88acf2e9cb
Set id: 6819df87-aaf8-49f8-a95d-acb6926d6848
Version: 4
Effective Time: 20150702
 
Microdermis Corporation