Dual Swab Scrub Swabstick
FDA Label NDC 67777-302

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Dual Swab Scrub Swabstick (NDC 67777-302). 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, purpose, indications & usage, warnings, stop use, ask a doctor, otc - do not use, otc - keep out of reach of children, 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                                          Purpose

Povidone Iodine Scrub 7.5% w/w                Antiseptic

Povidone Iodine Prep 10% w/w                  Antiseptic

Purpose

Uses

Povidone Iodine Scrub Swabstick - For scrubbing procedure site, prior to antiseptic application.

Povidone Iodine Prep Swabstick - For antiseptic application at procedure site.

Indications & Usage

Indications and Usage

  • For pre-operative patient skin preparation.

Warnings

​For External Use Only

Avoid contact with eyes. If contact occurs, flush with water.​

Stop Use

Stop use and ask a healthcare professional if;

  • condition worsens or persists for more than 72 hours
  • if pain, irritation, redness or swelling occurs

Ask A Doctor

Ask a doctor before use if you have:

  • deep puncture wounds
  • animal bites
  • serious wounds

Otc - Do Not Use

Do Not Use:

  • as a first aid antiseptic for more than 1 week
  • over large areas of the body

Otc - Keep Out Of Reach Of Children

Keep Out Of Reach Of Children

  • if swallowed, get medical help or contact a Poison Control Center immediately.​

Dosage And Administration

Directions

​For pre-operative patient skin preparation:

  • ​Apply to procedure site and allow to dry.
  • discard after single use.
  • If not ready for immediate venipuncture, cover the area with a dry sterile gauze.

    • As a first aid antiseptic:

    • ​clean affected area
    • apply to wound once or twice daily
    • may be covered with a sterile bandage
    • if bandaged let dry first

      • Tear at notch, remove applicator, use only once.

Inactive Ingredients

  • Povidone Iodine 7.5% Scrub Solution - Lauramide DEA, water
  • Povidone Iodine 10% Prep Solution - Anhydrous citric acid, disodium hydrogen phosphate, water

Other Information

  • Store at room temperature
  • Avoid excessive heat

Principal Display Panel

Dynarex Dual Swab Prep and Scrub Kit

Item 1207

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Pouches (1207 Pouches)

Pouches (1207 Pouches)

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