3-step First Aid Kit
FDA Label NDC 65734-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Swabplus Inc. for the product 3-step First Aid Kit (NDC 65734-000). 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 drug factsactive ingredients, purpose, uses, keep out of reach of children, directions, warnings, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredients

Antiseptic Swabs

Lidocaine Hydrochloride 1.0%

Benzalkonium Chloride 0.11%

Povidone Iodine swabs:

Povidone Iodine 10%, equal to available Iodine 1% for antiseptic

Purpose

Lidocaine Hydrochloride for Pain Relief

Benzalkonium Chloride for Antiseptic

Povidone Iodine for Antiseptis

Uses

First aid to help prevent infection, and temporarily reliever pain and itching associated with minor cuts. scrapes and burn

Keep Out Of Reach Of Children

Keeo out of reach of children

Directions

  • Do not use if label seal is broken prior to purchase.
  • Hold the swab vertically, with the color ring band tip upwards. Hold in the center of the stem with one hand and at the color band with the other.
  • Bend the tip at the color band to one side until it snaps.
  • Apply the product to the affected area.
  • Discard swab after use.

Warnings

For external use only. Keep out of eyes. Non-Sterile. Discontinue use if irritation occurs. Do not insert inear canal. Keep at room temperture. Avoid direct sunlight.

Do not use. Swabs if you are sensitive to any product ingredients. in the eyes. longer than one week unless directed by a doctor.

Stop use and ask a doctor if you have deep or punchture wounds, or serious burns. redness, irritation, sweeling or pain continues or increases, infection occurs

Other Information

For adult and children 2 and older: Clean affected area. Apply 1 to 3 times daily. May be covered with a bandage.

Children under 2 years of age: Consult a doctor.

Avoid storing at excessive heat.

Inactive Ingredients

Antiseptic swab: Dizolidinyl Urea, Methylparaben, Propylparaben, Water

Providone Iodine Swab: Glcerin, Water

Manufacturer Statement

Soft cotton tip swabs individually filled with Antiseptic or Iodine. Ready to use and convenient to carry for fast, clean, safe first aid.

Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 USA

The COLOR RING is copyrighted by Swabplus Inc. ©2007 SWABPLUS INC.

Package And Label

Image of first aid carton label

Image Of First Aid Carton Label (Firstaid100023)

Image Of First Aid Carton Label (Firstaid100023)

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