Bye Bye Diaper Rash

Manufacturer
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 Diaper Rash
Active ingredientSULFUR, CALCIUM SULFIDE, TOXICODENDRON PUBESCENS LEAF, LYTTA VESICATORIA
Label structure8 sections

Label contents#

Full prescribing information#

Bye Bye Diaper Rash

OTC - ACTIVE INGREDIENT SECTION

Cantharis 6X

Hepar sulphuris calcareum 12X

Rus toxicodendron 12X

Sulphur 12X

Bye Bye Diaper Rash

INACTIVE INGREDIENT SECTION

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

Bye Bye Diaper Rash

WARNINGS SECTION

Keep this and all medicines out of reach of children. Avoid spraying on clothing as this product will stain. Avoid contact with eyes. If this occurs rinse with warm water. If swallowed, seek professional assistance or contact a poison control center. Although all the ingredients are edible, this product isn't intended for internal use.

Bye Bye Diaper Rash

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of reach of children.

Bye Bye Diaper Rash

INDICATIONS & USAGE SECTION

For the temporary relief of skin rashes, itchy and inflamed skin, sore and swelling.

Bye Bye Diaper Rash

DOSAGE & ADMINISTRATION SECTION

For greater comfort in cold weather, warm the bottle in your pocket for a few minutes before using. Gently shake bottle before use. Clean and dry affected area before using. Spray directly onto skin rash. Apply up to 4 times daily as needed or directed by your health care professional. Clean any oil off spray cap after each use.

Bye Bye Diaper Rash

OTC - PURPOSE SECTION

Cantharis - for inflammation of the skin.

Hepar sulphuris calcareum - for unhealthy skin.

Rus toxicodendron - for red and swollen skin.

Sulphur - for itching skin, scaling, sores, and painful buring.

Bye Bye Diaper Rash

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelCartonCarton

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
64616-047-022021-01-29C16284748780-1ba0f9c33-18a1-a910-e053-dadaa90a0b85Bye Bye Diaper Rash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-047-01Bye Bye Diaper Rash59 mL in 1 BOTTLE, SPRAYLIQUID593
64616-047-02Bye Bye Diaper Rash1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-047BYE BYE DIAPER RASH (DIAPER RASH TREATMENT) LIQUID [VITALITY WORKS, INC.]3Legacy NDC, 2 package rows20171207_7d699efc-9aac-43f3-8b06-74520e7f0984.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q2
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BT2
SULFURACTIVE INGREDIENT70FD1KFU702
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A2
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51Q2
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BT2
SULFURACTIVE MOIETY70FD1KFU702
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A2
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
64616-04764616-047-01, 64616-047-02

Ingredients#

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

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

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
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact 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.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 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, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 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
5f8ae9ab-5e4f-7a60-e053-2991aa0a98177d699efc-9aac-43f3-8b06-74520e7f09842017-12-04WarningsExact identifier
spl id: 5f8ae9ab-5e4f-7a60-e053-2991aa0a9817
spl set id: 7d699efc-9aac-43f3-8b06-74520e7f0984

Reported adverse events (FAERS/openFDA)#

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