1. Home
  2. Labeler Index
  3. Natrural Creations, Inc.
  4. 43406-0631
  5. Label Information: Burn Relief

FDA Label for Burn Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. DOSAGE & ADMINISTRATION
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. REFERENCES
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn Relief Product Label

The following document was submitted to the FDA by the labeler of this product Natrural Creations, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.