Povidone Iodine Swabsticks 4" Triple

Povidone Iodine Swabsticks 4" Triple
SPL v2
SPL
SPL Set ID 45fdd9e3-031f-4741-868d-da606f60bb5a
Route
TOPICAL
Published
Effective Date 2022-01-05
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 2022-01-30

Description

Povidone-lodine USP10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-lodine USP10%

Use

for antiseptic skin preparation

Warnings
  • do not use if allergic to iodine
  • do not use in the eyes
Directions

apply locally as needed

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

For external use only.

  • 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
  • do not use if allergic to iodine
  • do not use in the eyes
Directions

apply locally as needed

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 If (Ask a doctor before use if)

injuries are

For external use only.

  • 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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