Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a546221f-f6da-4c70-95cf-14ec2242d2c1
Route
TOPICAL
Published
Effective Date 2010-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Povidone-iodine (.075 mL)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Nonoxynol-9 Polyethylene Glycol 300 Sodium Hydroxide Sodium Phosphate, Monobasic, Monohydrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1985-06-21

Description

Povidone Iodine, 7.5% w/v (equivalent to 0.75% titratable iodine)

Purpose

Antiseptic


Medication Information

Warnings and Precautions



Purpose

Antiseptic

Description

Povidone Iodine, 7.5% w/v (equivalent to 0.75% titratable iodine)

Uses
  • Surgical hand scrub for health care professionals
  • Health care antiseptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Section 42229-5



Section 50567-7



Section 50568-5



Section 53413-1



Section 53414-9



Warnings

For external use only.

Directions
As a surgical hand scrub for use by health care professionals
  • clean under nails with a nail pick
  • nails should be maintained with 1 millimeter free edge
  • wet hands and forearms
  • apply milliliter (teaspoon) or palmful to hands and forearms
  • scrub thoroughly paying particular attention to nails, cuticles and interdigital spaces
  • rinse and repeat scrub
For preparation of the skin prior to surgery
  • clean the affected area
  • apply to the operative site prior to surgery
As a first aid antiseptic

  • clean the affected area
  • apply a small amount of this product to the area 1-3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Do Not Use
  • in the eyes
  • on individuals who are allergic or sensitive to iodine
  • as a first aid antiseptic for longer than 1 week unless directed by a doctor
Active Ingredient

Povidone Iodine, 7.5% w/v (equivalent to 0.75% titratable iodine)

Label Information

Cat. No. 10-8304

NDC 50730-8304-2



TRIADINE™

POVIDONE-IODINE, USP

SCRUB SOLUTION

7.5% Topical Solution





ANTISEPTIC / GERMICIDE



  •  PRE-SURGICAL HAND SCRUB. Significantly reduces the number of micro-organisms on hand and forearms prior to surgery or patient care.
  • ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
  • FIRST AID ANTISEPTIC to help prevent the risk of infection in minor cuts, scrapes and burns.



FOR EXTERNAL USE ONLY!




4 Fluid Ounces (118 ml)

www.triad-group.net



TRIAD GROUP, INC.

700 West North Shore Drive

Hartland, WI 53029

MADE IN USA





Other Information
store at 15° - 30° C (59° - 86° F)

Inactive Ingredients
citric acid, glycerin, nonoxynol-9, PEG-300, sodium hydroxide, sodium phosphate, water
Ask A Doctor in Case Of
  • deep or puncture wounds
  • animal bites
  • serious burns

Stop Use and Ask A Doctor
if irritation and redness develop
Keep Out of Reach of Children

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


Structured Label Content

Uses (USES)
  • Surgical hand scrub for health care professionals
  • Health care antiseptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings and Precautions (34071-1)



Section 42229-5 (42229-5)



Section 50567-7 (50567-7)



Section 50568-5 (50568-5)



Section 53413-1 (53413-1)



Section 53414-9 (53414-9)



Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

For external use only.

Directions (DIRECTIONS)
As a surgical hand scrub for use by health care professionals
  • clean under nails with a nail pick
  • nails should be maintained with 1 millimeter free edge
  • wet hands and forearms
  • apply milliliter (teaspoon) or palmful to hands and forearms
  • scrub thoroughly paying particular attention to nails, cuticles and interdigital spaces
  • rinse and repeat scrub
For preparation of the skin prior to surgery
  • clean the affected area
  • apply to the operative site prior to surgery
As a first aid antiseptic

  • clean the affected area
  • apply a small amount of this product to the area 1-3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Do Not Use (Do not use)
  • in the eyes
  • on individuals who are allergic or sensitive to iodine
  • as a first aid antiseptic for longer than 1 week unless directed by a doctor
Active Ingredient (ACTIVE INGREDIENT)

Povidone Iodine, 7.5% w/v (equivalent to 0.75% titratable iodine)

Label Information (LABEL INFORMATION)

Cat. No. 10-8304

NDC 50730-8304-2



TRIADINE™

POVIDONE-IODINE, USP

SCRUB SOLUTION

7.5% Topical Solution





ANTISEPTIC / GERMICIDE



  •  PRE-SURGICAL HAND SCRUB. Significantly reduces the number of micro-organisms on hand and forearms prior to surgery or patient care.
  • ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
  • FIRST AID ANTISEPTIC to help prevent the risk of infection in minor cuts, scrapes and burns.



FOR EXTERNAL USE ONLY!




4 Fluid Ounces (118 ml)

www.triad-group.net



TRIAD GROUP, INC.

700 West North Shore Drive

Hartland, WI 53029

MADE IN USA





Other Information (OTHER INFORMATION)
store at 15° - 30° C (59° - 86° F)

Inactive Ingredients (INACTIVE INGREDIENTS)
citric acid, glycerin, nonoxynol-9, PEG-300, sodium hydroxide, sodium phosphate, water
Ask A Doctor in Case Of (Ask a doctor in case of)
  • deep or puncture wounds
  • animal bites
  • serious burns

Stop Use and Ask A Doctor (Stop use and ask a doctor)
if irritation and redness develop
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.


Advanced Ingredient Data


Raw Label Data

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