antiseptic povidone-lodine prep pad

antiseptic povidone-lodine prep pad
SPL v4
SPL
SPL Set ID 2cacf2e0-0192-4e0f-88a6-e3eee3af5471
Route
topical
Published
Effective Date 2022-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (10 mg)
Inactive Ingredients
glyceryl monostearate glycerin water

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-11-01 Until 2027-04-01

Purpose

First aid antiseptic Pain relieving cream

Description

Povidone-Iodine 10% w/w (1% available iodine)


Medication Information

Uses
  • First aid antiseptic to help prevent the risk of infection in minor cut, scrapes, and burns.
Purpose

First aid antiseptic

Pain relieving cream

Inactive Ingredients

purified water

Description

Povidone-Iodine 10% w/w (1% available iodine)

Warnings:
  • For external use only
  • Keep out of reach of children
  • Single use only
Drug Facts

Do Not Use:
  • in the eyes
  • over large areas of the body
  • as a first aid antiseptic for longer than one week unless directed by a physician
  • on individuals who are sensitive or allergic to iodine
  • if package is damaged or open
Active Ingredients

Povidone-Iodine 10% w/w

(1% available iodine)

directions for Use:
  • Clean the treatment area
  • Apply to the treatment area or operative site before surgery
Package Labeling: 82996 006 01

stop Use and Ask A Doctor If
  • irritation, redness, or symptoms develops
  • if the condition persists or gets worse.

Structured Label Content

Uses
  • First aid antiseptic to help prevent the risk of infection in minor cut, scrapes, and burns.
Purpose

First aid antiseptic

Pain relieving cream

Inactive Ingredients (Inactive ingredients)

purified water

Warnings:
  • For external use only
  • Keep out of reach of children
  • Single use only
Drug Facts

Do Not Use: (Do not use:)
  • in the eyes
  • over large areas of the body
  • as a first aid antiseptic for longer than one week unless directed by a physician
  • on individuals who are sensitive or allergic to iodine
  • if package is damaged or open
Active Ingredients (Active ingredients)

Povidone-Iodine 10% w/w

(1% available iodine)

directions for Use: (Directions for use:)
  • Clean the treatment area
  • Apply to the treatment area or operative site before surgery
Package Labeling: 82996 006 01 (Package labeling: 82996-006-01)

stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation, redness, or symptoms develops
  • if the condition persists or gets worse.

Advanced Ingredient Data


Raw Label Data

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