Everlit Care Products Antiseptic Mist Solution
FDA Label NDC 83807-033

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Everlit Global Inc. for the product Everlit Care Products Antiseptic Mist (NDC 83807-033). 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 - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, 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

Hydrogen Peroxide  3.0%

Otc - Purpose

Purpose

First Aid Antiseptic

Indications & Usage

Uses

  • First aid to help prevent the risk of infection in minor cuts, scrapes, and burns
  • Aids in the removal of phlegm, mucus, or other secretions associated with occational sore mouth

Warnings

Warnings

For external use only.

Do not use

  • in eyes or apply in large areas of the body
  • longer than one week
  • on deep puncture wounds, animal bites, or serious burns

Otc - Stop Use

Stop use and seek medical help, if

  • Swelling, rash, or fever develops
  • the condition persists or gets worse
  • sore mouth syptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Dosage & Administration

Directions 

For use as a first aid antiseptic

  • clean affected area
  • if bandaged, let dry first
  • apply small amount of product on the affected area 1 to 3 times daily
  • may be covered with a sterile bandage

    • For use as an oral debriding agent (oral rinse)

    • mix with an equal amount of water
    • swish around in the mouth over affected area for at least one minute and then spit out. Do not swallow.
    • use up to four times daily after meals and at bedtime or as directed by a dentist or doctor

      • Children under 12 years:use under supervision

      Children under 2 years of age: consult a dentist or doctor

Storage And Handling

Other Information

  • store at 68-77F (20-25C)

Inactive Ingredient

Inactive ingredients

Purified Water

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