Burn Relief Spray
FDA Label NDC 43406-0631

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natrural Creations, Inc. for the product Burn Relief (NDC 43406-0631). 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, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, 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

Active Ingredients (HPUS*): Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Picricum Acidum 12X, Urtica Urens 12X, Hypericum Perforatum 30C.

Otc - Purpose

Uses:  For the temporary relief of sunburns, burns, and itching skin.**

Indications & Usage

Uses: For the temporary relief of sunburns, burns, and itching skin.**

Dosage & Administration

Directions:  Spray topically as needed or as directed by a health care professional.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Warnings

WARNINGS:

  • FOR EXTERNAL USE ONLY.
  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do no use if TAMPER EVIDENT seal is broken or missing.​​​​​​

Inactive Ingredient

Inactive Ingredients:  Calendula (Marigold Flowering Tops) Extract, Carbomer 940, Ethyl Alcohol USP, Glycerin USP, Hypericum Perforatum (St. John's Wort) Extract, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxymethylglycinate.

Otc - Questions

Questions & Comments?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

References

*The letters "HPUS" indicate the components in this product are officially monographed in the Homoepathic Pharmacopeia of the United States.

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

Package Label.Principal Display Panel

NDC:  43406-0631-2

BURN RELIEF SPRAY

HOMEOPATHIC

2 fl  oz (60 mL) / 12% Alcohol

 UPC:  877730004758

* Please review the disclaimer below.