povidone iodine prep pad

povidone iodine prep pad
SPL v15
SPL
SPL Set ID c17603f2-3548-4225-b611-216c2763e51f
Route
topical
Published
Effective Date 2020-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (1 g)
Inactive Ingredients
citric acid monohydrate glycerin water sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-02-26

Purpose

Antiseptic

Description

Povidone Iodine USP 10% v/v


Medication Information

Uses
  • Health-care antiseptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns

Purpose

Antiseptic

Other Information

Store at room temperature: 59 o - 86 oF (15 o - 30 oC)

Description

Povidone Iodine USP 10% v/v

Principal Display Panel

Phoenix Healthcare Solutions LLC

An Innovative Medical Manufacturer

NDC 60913-999-02

200 Individual Pads

Povidone Iodine Prep Pads

Medium

For Individual, Professional and Hospital Use

Saturated with 10% Povidone Iodine for external use only

Latex Free

PIN DOT WOVEN

Do Not
  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body
  • use as a first aid antiseptic longer than 1 week unless directed by a doctor.

Discontinue use if irritation and redness develop.

Warnings:

For external use only

Directions:

For preparation of the skin prior to surgery



  • clean the affected area
  • apply a small amount of this product on the area

For use as a first aid antiseptic

  • clean the affected area
  • apply a small amount of this product on the area 1-3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first.
Active Ingredient

Povidone Iodine USP 10% v/v

Inactive Ingredients:

citric acid, glycerin, Makon 8, purified water, sodium hydroxide

Consult A Doctor in Case Of
  • deep or puncture wounds
  • animal bites
  • serious burns

Keep Out of Reach of Children

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



Stop Use and Consult A Doctor

if the condition persists or gets worse.


Structured Label Content

Uses
  • Health-care antiseptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns

Purpose

Antiseptic

Other Information (Other information)

Store at room temperature: 59 o - 86 oF (15 o - 30 oC)

Principal Display Panel

Phoenix Healthcare Solutions LLC

An Innovative Medical Manufacturer

NDC 60913-999-02

200 Individual Pads

Povidone Iodine Prep Pads

Medium

For Individual, Professional and Hospital Use

Saturated with 10% Povidone Iodine for external use only

Latex Free

PIN DOT WOVEN

Do Not (Do not)
  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body
  • use as a first aid antiseptic longer than 1 week unless directed by a doctor.

Discontinue use if irritation and redness develop.

Warnings:

For external use only

Directions:

For preparation of the skin prior to surgery



  • clean the affected area
  • apply a small amount of this product on the area

For use as a first aid antiseptic

  • clean the affected area
  • apply a small amount of this product on the area 1-3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first.
Active Ingredient (Active ingredient)

Povidone Iodine USP 10% v/v

Inactive Ingredients: (Inactive ingredients:)

citric acid, glycerin, Makon 8, purified water, sodium hydroxide

Consult A Doctor in Case Of (Consult a doctor in case of)
  • deep or puncture wounds
  • animal bites
  • serious burns

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

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



Stop Use and Consult A Doctor (Stop use and consult a doctor)

if the condition persists or gets worse.


Advanced Ingredient Data


Raw Label Data

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