FDA.reportPublic FDA data

Burn

Manufacturer
MBI Distributing Inc.
Effective date
2011-07-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:03:16

Label at a glance#

ProductBurn
Active ingredientAESCULUS HIPPOCASTANUM FLOWER, ALOE, ARNICA MONTANA, BERBERIS VULGARIS ROOT BARK, CALENDULA OFFICINALIS FLOWERING TOP, SALICYLIC ACID, ZINC SULFATE HEPTAHYDRATE
Label structure14 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

WARNINGS SECTION

For external use only.

OTC - QUESTIONS SECTION

Questions?

1.800.321.3740
Mon-Fri, 9am-5pm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn Spray CartonBurn Spray Carton

OTC - DO NOT USE SECTION

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 SECTION

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

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58301-181-282020-01-31C16284748780-19d75b9d0-5b00-f424-e053-dadaa90a57ce9a6f173c-7dcf-4a1c-8817-486eeace753d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58301-181-28Burn60 mL in 1 BOTTLE, SPRAYSPRAY606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58301-181BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]6Legacy NDC, 1 package rows20110802_9a6f173c-7dcf-4a1c-8817-486eeace753d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AESCULUS HIPPOCASTANUM FLOWERACTIVE INGREDIENTKK0Z92II8M6
ALOEACTIVE INGREDIENTV5VD430YW96
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW6
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0U6
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ6
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ6
ZINC SULFATE HEPTAHYDRATEACTIVE INGREDIENTN57JI2K7WP6
AESCULUS HIPPOCASTANUM FLOWERACTIVE MOIETYKK0Z92II8M6
ALOEACTIVE MOIETYV5VD430YW96
ARNICA MONTANAACTIVE MOIETYO80TY208ZW6
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0U6
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ6
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ6
ZINC CATIONACTIVE MOIETY13S1S8SF376
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ16
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC16
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP6
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FT6
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH6
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ46
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V36
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO6
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58301-18158301-181-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
AESCULUS HIPPOCASTANUM FLOWERKK0Z92II8MACTIB
ALOEV5VD430YW9ACTIB
ARNICA MONTANAO80TY208ZWACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
ZINC SULFATE HEPTAHYDRATEN57JI2K7WPACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BICARBONATE8MDF5V39QOIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BENZYL ALCOHOLLKG8494WBHIACT
AVOCADO OIL6VNO72PFC1IACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 385 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE / ORAL238 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING / ORAL83 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVENOUS812 mgExact identifier — unii candidate
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4LOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCAPSULE / ORAL563 mgExact identifier — unii candidate
28 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates

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
ca25ffb3-f69c-4d2c-aa94-525ef518df919a6f173c-7dcf-4a1c-8817-486eeace753d2011-07-28WarningsExact identifier
spl id: ca25ffb3-f69c-4d2c-aa94-525ef518df91
spl set id: 9a6f173c-7dcf-4a1c-8817-486eeace753d

Reported adverse events (FAERS/openFDA)#

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