1201, 1202 Povidone Iodine Swabsticks

1201, 1202 Povidone Iodine Swabsticks
SPL v15
SPL
SPL Set ID 564ec54b-353e-45a8-85e8-a39f89488d9c
Route
TOPICAL
Published
Effective Date 2016-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Glycerin Polysorbate 80 Sodium Citrate Sodium Phosphate, Dibasic, Anhydrous Citric Acid Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-09-13

Description

Section Text Active Ingredient                                                        Purpose Povidone Iodine 10% w/v (9.85% w/w/)                        Antiseptic                          

Purpose

Purpose: First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns. For preparation of the skin prior to surgery. Helps reduce bacteria that can potentially cause skin infections.


Medication Information

Indications and Usage

For use as an

  • first aid antiseptic

  • pre-operative skin preperation

Purpose

Purpose: First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns. For preparation of the skin prior to surgery. Helps reduce bacteria that can potentially cause skin infections.

Description

Section Text Active Ingredient                                                        Purpose Povidone Iodine 10% w/v (9.85% w/w/)                        Antiseptic                          

Section 55106-9

Section Text

Active Ingredient                                                        Purpose

Povidone Iodine 10% w/v (9.85% w/w/)                        Antiseptic                          

Purpose:



Purpose:

  • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infections.
Stop Use:



  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Warnings:

Section Text

  • FOR EXTERNAL USE ONLY

Do Not Use:


  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Other Information:

Store at room temperature.

Avoid excessive heat

Inactive Ingredients

Inactive ingredients: Citric acid, glycerin, polysorbate 80, sodium citrate USP, sodium phosphate dibasic, water

Principal Display Panel

Principal Display Panel

Povidone Iodine Swabsticks 1201 & 1202

PVP 419.jpg

Directions Povidone Iodine:

Tear at notch, remove applicator, use only once.

As a first aid antiseptic

  • clean affected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged let dry.


For preoperative patient skin preparation



  • clean area
  • apply to operative site prior to surgery using the applicator



Keep Out of Reach of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.



Ask A Doctor Before Use If You Have:



  • Deep puncture wounds
  • Animal bites
  • Serious burns


Structured Label Content

Indications and Usage (34067-9)

For use as an

  • first aid antiseptic

  • pre-operative skin preperation

Section 55106-9 (55106-9)

Section Text

Active Ingredient                                                        Purpose

Povidone Iodine 10% w/v (9.85% w/w/)                        Antiseptic                          

Purpose:



Purpose:

  • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infections.
Stop Use:



  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Warnings:

Section Text

  • FOR EXTERNAL USE ONLY

Do Not Use: (Do not use:)


  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Other Information: (Other information:)

Store at room temperature.

Avoid excessive heat

Inactive Ingredients

Inactive ingredients: Citric acid, glycerin, polysorbate 80, sodium citrate USP, sodium phosphate dibasic, water

Principal Display Panel

Principal Display Panel

Povidone Iodine Swabsticks 1201 & 1202

PVP 419.jpg

Directions Povidone Iodine: (Directions Povidone iodine:)

Tear at notch, remove applicator, use only once.

As a first aid antiseptic

  • clean affected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged let dry.


For preoperative patient skin preparation



  • clean area
  • apply to operative site prior to surgery using the applicator



Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.



Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)



  • Deep puncture wounds
  • Animal bites
  • Serious burns


Advanced Ingredient Data


Raw Label Data

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