Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3f9e9861-91e1-4ef5-a41a-f389c16ebdfb
Route
TOPICAL
Published
Effective Date 2009-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Povidone-iodine (.10 L)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Sodium Hydroxide Water

Identifiers & Packaging

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

Description

Povidone Iodine,10% (Equivalent to 1% titratable iodine)

Purpose

Antiseptic


Medication Information

Warnings and Precautions



Purpose

Antiseptic

Description

Povidone Iodine,10% (Equivalent to 1% titratable iodine)

Uses
  • Health-care antiseptic for preparation of the skin prior to surgery
  • First id 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
For preparation of the skin prior to surgery:
  • 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
  • use as a first aid antiseptic for longer than one week
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body
Active Ingredient

Povidone Iodine,10% (Equivalent to 1% titratable iodine)

Label Information

Triad



Cat. No. 10-8428

NDC 50730-8428-6





TRIADINE

POVIDONE-IODINE, USP

WHIRLPOOL CONCENTRATE

10% Solution



Antiseptic / Germicide


For general antiseptic use in Whirlpool or other hydrotherapy tanks.



For External Use Only!





128 Fluid Ounces (3.785 L)









Other Information
Store at room temperature 20° - 25° C (68° - 77° F)

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

Stop Use and Ask A Doctor
  • if condition persists or gets worse
  • if irritation and redness develop and persist for over 72 hours.

Keep Out of Reach of Children

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


Structured Label Content

Uses (USES)
  • Health-care antiseptic for preparation of the skin prior to surgery
  • First id 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)
For preparation of the skin prior to surgery:
  • 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
  • use as a first aid antiseptic for longer than one week
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body
Active Ingredient (ACTIVE INGREDIENT)

Povidone Iodine,10% (Equivalent to 1% titratable iodine)

Label Information (LABEL INFORMATION)

Triad



Cat. No. 10-8428

NDC 50730-8428-6





TRIADINE

POVIDONE-IODINE, USP

WHIRLPOOL CONCENTRATE

10% Solution



Antiseptic / Germicide


For general antiseptic use in Whirlpool or other hydrotherapy tanks.



For External Use Only!





128 Fluid Ounces (3.785 L)









Other Information (OTHER INFORMATION)
Store at room temperature 20° - 25° C (68° - 77° F)

Inactive Ingredients (INACTIVE INGREDIENTS)
citric acid, glycerin, nonoxynol-9, sodium hydroxide, 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 condition persists or gets worse
  • if irritation and redness develop and persist for over 72 hours.

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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