FDA.reportPublic FDA data

Bye Bye Burns

Manufacturer
Vitality Works, Inc | Vitality Works, Inc.
Effective date
2017-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:09:00

Label at a glance#

ProductBye Bye Burns
Active ingredientATROPA BELLADONNA, LYTTA VESICATORIA, RANUNCULUS BULBOSUS, URTICA DIOICA
Label structure8 sections

Label contents#

Full prescribing information#

Bye Bye Burns

OTC - ACTIVE INGREDIENT SECTION

Belladonna 6X

Cantharis 6X

Ranunculus bulbosa 6X

Urtica dioica 6X

Bye Bye Burns

INACTIVE INGREDIENT SECTION

Natural coconut oil, virgin olive oil, omega-3 shark liver oil, natural vitamin E.

Bye Bye Burns

WARNINGS SECTION

Avoid contact with eyes. If symptoms persist for more than 7 days, discontinue use and contact your health care professional. In case of accidental overdose seek professional assistance or contact a poison control center immediately. All the ingredients are edible, but this product is not intended for internal use. Avoid spraying on clothing as the product will stain. In case of severe burns, or burns over large areas of the body, consult a doctor. Stop use and consult a doctor if the conditions persist or get worse.

Bye Bye Burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Bye Bye Burns

INDICATIONS & USAGE SECTION

For the temporary relief of skin burns and pain from contact with hot surfaces, scalding, and from the sun. For the temporary reief of vesicular eruptions like blisters, and inflammation after a burn.

Bye Bye Burns

DOSAGE & ADMINISTRATION SECTION

Adults or children over 2 years of age, apply to affected area up to 3-4 times daily. The harder you depress the sprayer cap, the more it will be directed in a stream rather than in a mist. Most of the oil will absorb directly into the skin within 15 minutes of application.

Bye Bye Burns

OTC - PURPOSE SECTION

Belladonna  - burning of the skin from contact

Cantharis  - burns, scalds, and inflammation of the skin

Ranunculus bulbosa - blistering of the skin after a burn

Urtica dioica - burns, scalds, sunburns and itching from burns.

Bye Bye Burns

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonLabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64616-046-022021-01-29C16284748780-1ba0f9c33-2cd9-a910-e053-dadaa90a0b85Bye Bye Burns

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-046-01Bye Bye Burns59 mL in 1 BOTTLE, SPRAYSPRAY593
64616-046-02Bye Bye Burns1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-046BYE BYE BURNS (TOPICAL SKIN SPRAY) SPRAY [VITALITY WORKS, INC]3Legacy NDC, 2 package rows20171208_7c6c3a42-6dc9-400f-9bfd-59cdaf33ca41.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H2
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BT2
RANUNCULUS BULBOSUSACTIVE INGREDIENTAEQ8NXJ0MB2
URTICA DIOICAACTIVE INGREDIENT710FLW4U462
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H2
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BT2
RANUNCULUS BULBOSUSACTIVE MOIETYAEQ8NXJ0MB2
URTICA DIOICAACTIVE MOIETY710FLW4U462
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ12
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E2
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEU2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-04664616-046-01, 64616-046-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
OLIVE OIL6UYK2W1W1EIACT
SHARK LIVER OIL4B24275HEUIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB
URTICA DIOICA710FLW4U46ACTIB

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 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact 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
5f8ad9e0-ddbe-1c24-e053-2a91aa0ad0707c6c3a42-6dc9-400f-9bfd-59cdaf33ca412017-12-04WarningsExact identifier
spl id: 5f8ad9e0-ddbe-1c24-e053-2a91aa0ad070
spl set id: 7c6c3a42-6dc9-400f-9bfd-59cdaf33ca41

Reported adverse events (FAERS/openFDA)#

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