Label: PROVODINE- providone iodine emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 59426-001-03, 59426-001-04, 59426-001-16 - Packager: Microdermis Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 2, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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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
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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
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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.
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INGREDIENTS AND APPEARANCE
PROVODINE
providone iodine emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59426-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 7.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:59426-001-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59426-001-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59426-001-03 100 in 1 BOX 3 3 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/15/2014 Labeler - Microdermis Corporation (969967988) Establishment Name Address ID/FEI Business Operations Accupac, Inc 061595175 MANUFACTURE(59426-001) Establishment Name Address ID/FEI Business Operations ACUPAC PACKAGING INC 037138013 manufacture(59426-001)
