Burn
FDA Label NDC 58301-181

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mbi Distributing Inc. for the product Burn (NDC 58301-181). 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, inactive ingredient, indications & usage, dosage & administration, otc - purpose, otc - keep out of reach of children, warnings, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Aesculus hippocastanum 4x, Aloe socotrina 4x, Arnica montana 4x, Berberis vulgaris 4x, Calendula officinalis 4x, Salicylicum acidum 2x, Zincum metallicum 3x

Inactive Ingredient

deionized water, propylene glycol, polysorbate 20, glycerine, sodium bicarbonate, MSM, Dimethylaminoethanol, citric acid, potassium sorbate, benzyl alcohol, trace minerals (trona), avocado oil, and vitamin E

Indications & Usage

Temporarily relieves symptoms of minor burns, superficial scalds, sunburn, and other minor skin irritations such as:

  • redness
  • stinging
  • burning
  • itching
  • minor pain
  • dryness
  • as per homeopathic materia medica

Dosage & Administration

Directions

  • Adults and children 3 years of age and older:
  • clean the burned area(s)
  • apply topically as needed not more than 12 times daily
  • area may be covered with a sterile bandage
  • children under 3 years of age: consult a physician


Otc - Purpose

Aesculus hippocastanum...................................................Venous Stasis

Aloe socotrina...........................................................................Redness

Arnica montana...........................................................................Burning

Berberis vulgaris..........................................................................Burning

Calendula officinalis.....................................................................Healing

Salicylicum acidum.......................................................Burning and Heat

Zincum metallicum.............................................................Pain Reliever

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Otc - Questions

Questions?1.800.321.3740Mon-Fri, 9am-5pm

Package Label.Principal Display Panel

Burn Spray Carton (Burnspraycarton)

Burn Spray Carton (Burnspraycarton)

Otc - Do Not Use

Do not

  • use if you are allergic to salicylates (although this product does not contain aspirin)
  • use in the eyes
  • apply over large areas of the body
  • use longer than 1 week unless directed by a doctor
  • ingest


Otc - Ask Doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

Otc - When Using

When using this product

  • use only as directed
  • test on a small area before use.  This product may cause allergic reaction in some individuals.
  • wash hands before and after using
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • excessive skin irritation occurs

Storage And Handling

  • store at room temperature
  • Tamper Evident:  Do not use if imprinted seal around cap is broken or missing.

* Please review the disclaimer below.