PROVODINE- providone iodine emulsion

Provodine by

Drug Labeling and Warnings

Provodine by is a Otc medication manufactured, distributed, or labeled by Microdermis Corporation, Accupac, Inc, ACUPAC PACKAGING INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PROVODINE 
providone iodine emulsion

Product 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)