Lights Povidone Iodine Swabsticks Solution
FDA Label NDC 61333-221

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lights Medical Manufacture Co., Ltd. for the product Lights Povidone Iodine Swabsticks (NDC 61333-221). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, otc - ask doctor, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Povidone-Iodine USP (10%)

Otc - Purpose

Purpose:

Antiseptic

Indications & Usage

Use:

Health care antiseptic for prepapration of skin prior to surgery.

First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Warnings

For external use only

Otc - Do Not Use

Do not use

  • in the eyes
  • longer than one week unless directed by a physician
  • on individuals who are allergic or sensitive to iodine
  • or apply over large areas of the body

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, seek medical assistance or immediately contact a Poison Control Center

Otc - Ask Doctor

Stop use and ask a doctor if

  • irritation and redness develop.
  • condition persists for more than 72 hours
  • in case of deep or puncture wounds, animal bites, or serious burns

Directions

  • clean the affacted area
  • for preparation of the skin prior surgery: remove swabstick, apply the product to the operative site prior to surgery
  • for first aid antiseptic: clean the affected area, apply a small anount of the product to the area 1-3 times daily.
  • maybe covered with a sterile bandage.
  • if bandaged, let dry first.

Other Information

  • protect from freezing, avoid excessive heat

Inactive Ingredient

Inactive Ingredient

Citric acid, purified water, Sodium phosphate dibasic

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