Provodine

Provodine
SPL v4
SPL
SPL Set ID 6819df87-aaf8-49f8-a95d-acb6926d6848
Route
TOPICAL
Published
Effective Date 2014-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (7.5 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-09-15

Description

Povidone-iodine 7.5%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-iodine 7.5%

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

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.

Questions?

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

Active Ingredient

Povidone-iodine 7.5%

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.

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.

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Structured Label Content

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.

Purpose

Antiseptic

Warnings

For external use only

Do not use in the eyes

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.

Questions?

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

Active Ingredient (Active ingredient)

Povidone-iodine 7.5%

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.

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

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