Povidone-iodine Prep Sponge Sticks Sterile

Povidone-iodine Prep Sponge Sticks Sterile
SPL v4
SPL
SPL Set ID bb62784a-d7b7-471e-9aed-0c6d2e349c3a
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Hydroxyethyl Cellulose, Unspecified Nonoxynol-10 Glycerin Sodium Hydroxide Potassium Iodide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-04-27

Description

Povidone-Iodine USP 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine USP 10%

Use
  • For preparation prior to surgery 
  • Helps to reduce bacteria that can potentially cause skin infection.
Warnings

For external use only.

Do not apply to persons allergic to iodine

Directions

Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.

Do Not Use
  • in the eyes
Active Ingredient

Povidone-Iodine USP 10%

Other Information

• 1% titratable iodine • latex free • for hospital or professional use only

Package Labeling:

Inactive Ingredients

Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water

Ask A Doctor Before Use If 

injuries are • deep wounds

• puncture wounds • serious burns

Stop Use and Ask A Doctor If

• irritation and redness develop 

• condition persists for more than 72 hours • infection occurs

Avoid pooling beneath the patient.Prolonged exposure to wet solution may cause skin irritation.

Keep Out of Reach of Children.

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


Structured Label Content

Use
  • For preparation prior to surgery 
  • Helps to reduce bacteria that can potentially cause skin infection.
Purpose

Antiseptic

Warnings

For external use only.

Do not apply to persons allergic to iodine

Directions

Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.

Do Not Use (Do not use)
  • in the eyes
Active Ingredient (Active ingredient)

Povidone-Iodine USP 10%

Other Information (Other information)

• 1% titratable iodine • latex free • for hospital or professional use only

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water

Ask A Doctor Before Use If  (Ask a doctor before use if )

injuries are • deep wounds

• puncture wounds • serious burns

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• irritation and redness develop 

• condition persists for more than 72 hours • infection occurs

Avoid pooling beneath the patient.Prolonged exposure to wet solution may cause skin irritation.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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