Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 313416b8-60b2-4a77-9b56-5c507aae9072
Route
TOPICAL
Published
Effective Date 2021-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1 g)
Inactive Ingredients
Glycerin Hydroxyethyl Cellulose (2000 Mpa.s At 1%) Nonoxynol-10 Anhydrous Citric Acid Sodium Hydroxide Water Potassium Iodide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-22

Description

Povidone Iodine USP 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone Iodine USP 10%

Use

For preparation of the skin prior to surgery

Section 50565-1
  • Keep out of reach of children
  • If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
Warnings

For external use only.

Do not apply to persons allergic to iodine.

Directions

Clean area. Apply to the operative site prior to surgery

Active Ingredient

Povidone Iodine USP 10%

Other Information
  • 1 % titratable iodine. Store at ambient temperatures
Inactive Ingredients

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

Do Not Use in the Eyes.
  • Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
Principal Display Panel 0.5 Ml Item Label

NDC 0404-0121-01

HENRY SCHEIN ®

REF 570-1543

POVIDONE-IODINE

PREP PAD

10% Povidone-Iodine

For Professional and Hospital Use

Not Made with Natural Rubber Latex

HENRY SCHEIN

SEAL OF EXCELLENCE ®

1/Pouch


Structured Label Content

Use

For preparation of the skin prior to surgery

Section 50565-1 (50565-1)
  • Keep out of reach of children
  • If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
Purpose

Antiseptic

Warnings

For external use only.

Do not apply to persons allergic to iodine.

Directions

Clean area. Apply to the operative site prior to surgery

Active Ingredient (Active ingredient)

Povidone Iodine USP 10%

Other Information (Other information)
  • 1 % titratable iodine. Store at ambient temperatures
Inactive Ingredients (Inactive ingredients)

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

Do Not Use in the Eyes. (Do not use in the eyes.)
  • Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
Principal Display Panel 0.5 Ml Item Label (Principal Display Panel - 0.5 mL Item Label)

NDC 0404-0121-01

HENRY SCHEIN ®

REF 570-1543

POVIDONE-IODINE

PREP PAD

10% Povidone-Iodine

For Professional and Hospital Use

Not Made with Natural Rubber Latex

HENRY SCHEIN

SEAL OF EXCELLENCE ®

1/Pouch


Advanced Ingredient Data


Raw Label Data

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