Povidone Iodine Swabsticks

Povidone Iodine Swabsticks
SPL v3
SPL
SPL Set ID dde2c33c-c6e0-4339-ac3b-f40cc187105e
Route
TOPICAL
Published
Effective Date 2024-11-20
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 2023-09-05

Description

Povidone-lodine USP10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-lodine USP10%

Use

for antiseptic skin preparation

Warnings

For external use only.

Directions

apply locally as needed

Drug Facts

Do Not Use
  • if allergic to lodine 
  • do not use in the eyes
Active Ingredient

Povidone-lodine USP10%

Other Information

■1% titratable iodine ■For hospital or professional use only ■Store at room temperature. ■Avoid excessive heat. ■Not made with natural rubber latex.

Package Labeling:

Inactive Ingredients:

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

Ask A Doctor Before Use 

if injuries are 

  • deep or puncture wounds
  • serious burns
Stop Use and Ask A Doctor If
  • redness,irritation,swelling or pain persists or increases
  • infection occurs
Keep Out of Reach of Children.

In case of accidental ingestion,seek professional assistance or consult a poison control center immediately.  Avoid pooling beneath patient.


Structured Label Content

Use

for antiseptic skin preparation

Purpose

Antiseptic

Warnings

For external use only.

Directions

apply locally as needed

Drug Facts

Do Not Use (do not use)
  • if allergic to lodine 
  • do not use in the eyes
Active Ingredient (Active ingredient)

Povidone-lodine USP10%

Other Information (Other information)

■1% titratable iodine ■For hospital or professional use only ■Store at room temperature. ■Avoid excessive heat. ■Not made with natural rubber latex.

Package Labeling:

Inactive Ingredients: (Inactive ingredients:)

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

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

if injuries are 

  • deep or puncture wounds
  • serious burns
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • redness,irritation,swelling or pain persists or increases
  • infection occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion,seek professional assistance or consult a poison control center immediately.  Avoid pooling beneath patient.


Advanced Ingredient Data


Raw Label Data

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