FDA.reportPublic FDA data

Burn Complex

Manufacturer
Nova Homeopathic Therapeutics, Inc.
Effective date
2011-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:28

Label at a glance#

ProductBurn Complex
Active ingredientACONITUM NAPELLUS, APIS MELLIFERA, ARNICA MONTANA, BERBERIS VULGARIS ROOT BARK, CALENDULA OFFICINALIS FLOWERING TOP, LYTTA VESICATORIA, ACTIVATED CHARCOAL, CAUSTICUM, ECHINACEA ANGUSTIFOLIA, NITROGLYCERIN, HYPERICUM PERFORATUM, URTICA URENS
Label structure9 sections

Label contents#

Full prescribing information#

Purpose:

OTC - PURPOSE SECTION

Suggested use for one or more of the following symptoms:

Burns, sunstroke, blistering, skin redness, dizziness and nausea.

Usage and Dosage:

INDICATIONS & USAGE SECTION

For oral use only.

DOSAGE & ADMINISTRATION SECTION

Adults:

        In Acute Phase:
                12-15 drops, every half hour until relief occurs
        When Relief Occurs:
                12-15 drops, 4-6 times per day

Children 2-12 years:

        8-10 drops, 4-6 times per day

Infants 0-24 months:

        4 drops, 4-6 times per day

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

If symptoms persist, consult a physician.

Do not use if ring on bottom of cap is broken or missing.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION


Aconitum napellus 12X, Apis mellifica 4X, Arnica montana 3X, Berberis vulgaris 4X, Calendula officinalis 3X, Cantharis 4X, Carbo vegetabilis 12X, Causticum 3X, Echinacea angustifolia 3X, Glonoinum 6X, Hypericum perforatum 3X, Urtica urens 3X

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alcohol, 20% USP

OTC - QUESTIONS SECTION

Manufactured by Nova Homeopathic Therapeutics Inc., Albuquerque, New Mexico USA 87109
1-800-225-8094

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Burn Complex Product

Burn Complex Product
Burn Complex Product

Burn Complex Bottle Label

Burn Complex Bottle
Burn Complex Bottle

Burn Complex Box

Burn Complex BoxBurn Complex Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52731-7025-22019-11-13C16284748780-197449f38-c653-f6ea-e053-dbdaa90aa703Burn Complex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52731-7025-1Burn Complex50 mL in 1 BOTTLELIQUID501
52731-7025-2Burn Complex1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52731-7025BURN COMPLEX (ACONITUM NAPELLUS 12X, APIS MELLIFICA 4X, ARNICA MONTANA 3X, BERBERIS VULGARIS 4X, CALENDULA OFFICINALIS 3X, CANTHARIS 4X, CARBO VEGETABILIS 12X, CAUSTICUM 3X, ECHINACEA ANGUSTIFOLIA 3X,GLONOINUM 6X, HYPERICUM PERFORATUM 3X, URTICA URENS 3X) LIQUID [NOVA HOMEOPATHIC THERAPEUTICS, INC.]1Legacy NDC, 2 package rows20111221_85484b08-ecf3-4a19-841f-964bab3cad91.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H101
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z1
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0U1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU1
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNB1
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BT1
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS31
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF91
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H101
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0U1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
CAUSTICUMACTIVE MOIETYDD5FO1WKFU1
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNB1
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BT1
NITROGLYCERINACTIVE MOIETYG59M7S0WS31
URTICA URENSACTIVE MOIETYIHN2NQ5OF91

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52731-702552731-7025-1, 52731-7025-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARNICA MONTANAO80TY208ZWACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
CAUSTICUMDD5FO1WKFUACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
NITROGLYCERING59M7S0WS3ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
URTICA URENSIHN2NQ5OF9ACTIB
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
5ca4be61-0d88-4635-bf1f-c65587f3316285484b08-ecf3-4a19-841f-964bab3cad912011-06-01WarningsExact identifier
spl id: 5ca4be61-0d88-4635-bf1f-c65587f33162
spl set id: 85484b08-ecf3-4a19-841f-964bab3cad91

Reported adverse events (FAERS/openFDA)#

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