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Provodine

Dosage form: emulsion
Ingredients: POVIDONE-IODINE 7.5mg in 1mL
Labeler: Microdermis Corporation
NDC Code: 59426-001

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.

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

Package/Label Principal Display Panel


PROVODINE 
providone iodine emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59426-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
YELLOW WAX 
BENZALKONIUM CHLORIDE 
BUTYLENE GLYCOL 
C13-14 ISOPARAFFIN 
MEDIUM-CHAIN TRIGLYCERIDES 
CETYL ALCOHOL 
EDETATE DISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
GLYCERYL LAURATE 
GLYCERYL MONOSTEARATE 
LAURETH-7 
NONOXYNOL-9 
OCTOXYNOL-9 
PIDOLIC ACID 
PEG-100 STEARATE 
POLYACRYLAMIDE (10000 MW) 
POLYGLYCERYL-3 DIISOSTEARATE 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) 
WATER 
BETASIZOFIRAN 
STEARIC ACID 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:59426-001-16473 mL in 1 BOTTLE
2NDC:59426-001-04118 mL in 1 BOTTLE
3NDC:59426-001-03100 PACKET in 1 BOX
33 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/15/2014
Labeler - Microdermis Corporation (969967988)
Establishment
NameAddressID/FEIOperations
Accupac, Inc061595175MANUFACTURE(59426-001)
Establishment
NameAddressID/FEIOperations
ACUPAC PACKAGING INC037138013manufacture(59426-001)

 
Microdermis Corporation

Medically reviewed on Jul 2, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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