FDA.reportPublic FDA data

BURN RELIEF SPRAY

Manufacturer
Natrural Creations, Inc. | Ohm Pharma, Inc.
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:35:11

Label at a glance#

ProductBURN RELIEF
Active ingredientARSENIC TRIOXIDE, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, PICRIC ACID, URTICA URENS, HYPERICUM PERFORATUM
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

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 SECTION

Questions & Comments?

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

REFERENCES SECTION

*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

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130877730004758GTIN-13: 0877730004758
EAN-13: 0877730004758
GTIN-12: 877730004758
UPC-A: 877730004758
GTIN storage (14 digits): 00877730004758		BURN RELIEF SPRAY.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0631-22023-01-10C16284748780-1d6a99b39-3782-a426-e053-dadaa90af4c2BURN RELIEF SPRAY
43406-0631-22022-01-28C16284748780-1d6a99b39-3782-a426-e053-dadaa90af4c2BURN RELIEF SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0631-2BURN RELIEF60 mL in 1 BOTTLE, SPRAYSPRAY604

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-063143406-0631-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CAUSTICUMDD5FO1WKFUACTIB
PICRIC ACIDA49OS0F91SACTIB
URTICA URENSIHN2NQ5OF9ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQIACT
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
HYPERICUM PERFORATUM FLOWERA6V4CUE7PVIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BURN RELIEFARSENIC TRIOXIDE, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, PICRIC ACID, URTICA URENS, HYPERICUM PERFORATUMNatrural Creations, Inc.79c80c6c-1fd9-4b32-81e0-ff6a1f6102272025-11-13WarningsExact identifier
ndc (package): 43406-0631-2
ndc (product): 43406-0631
ndc11 (package): 43406063102
spl id: 8e095c7b-e389-483a-a02e-9556504f2283
spl set id: 79c80c6c-1fd9-4b32-81e0-ff6a1f610227

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.