Isodine Copitos
FDA Label NDC 65734-511

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 Isodine Copitos (NDC 65734-511). 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 ingredient, purpose, keep out of reach of children, directions, warnings, administration, inactive ingredients, manufacturer statement, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredient

Povidone iodine 10%, equal to 1% available Iodine

Purpose

Antiseptic

Uses First aid to help prevent infection due to minor cuts, scrapes and burns.

Keep Out Of Reach Of Children

if swallowed, get medical help of contact a Poison Control Center right away.

Directions

  • Hold the swab vertically, with the color ring tip upwards, Hold n the center of the tube with one hand at the color ring with the other.
  • Gently snap the tip with the color ring, Formula inside the tube flows down and fills the opposite tip.
  • Apply the product to the affected area.
  • Discard swab after use.

Warnings

For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation.

Do not use. If you are sensitive to Iodine. Longer than one week unless directed by a doctor.

Stop use and ask a doctor. If you have deep or puncture wounds, or serious burns. redness, irritation, swelling or pain continue or increas., infedtion occurs.

Administration

For adults and children 2 and older: for minor wounds, burns and infections, apply directly to affected area. May be covered with a bandage.

Children under 2 years of age: Do not use, consult a doctor.

Other information: Store art room temperature, Avoid direct sunlight, excessive heat and moisture.

Inactive Ingredients

Glycerin, water

Manufacturer Statement

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

Imported and Distributed by Boehringer Ingelheim

Package And Labeling

Image of iodine carton label

Image Of Iodine Carton Label (Isodine02511)

Image Of Iodine Carton Label (Isodine02511)

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