FDA.reportPublic FDA data

BYE-BYE CRADLE CAP

Manufacturer
Tubby Todd
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:40

Label at a glance#

ProductBYE-BYE CRADLE CAP
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

Helps eliminate skin and scalp scaling, flaking, irritation, redness, and itching associated with Seborrheic Dermatitis.

Dosage and administration

For best results use at least twice a week or as directed by a doctor. Wet area thoroughly, massage onto scalp and skin, rinse.

Storage and handling

Do not use if quality seal is broken or missing Protect from excessive heat (40°C/104°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

PYRITHIONE ZINC 0.95%

Purpose

OTC - PURPOSE SECTION

SEBORRHEIC DERMATITIS

Uses

INDICATIONS & USAGE SECTION

Helps eliminate skin and scalp scaling, flaking, irritation, redness, and itching associated with Seborrheic Dermatitis.

Warnings

WARNINGS SECTION

For External Use Only

When using this product

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Ask a doctor before use if you have a condition that covers a large area of the body.
  • Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For best results use at least twice a week or as directed by a doctor. Wet area thoroughly, massage onto scalp and skin, rinse.

Other Information

STORAGE AND HANDLING SECTION

  • Do not use if quality seal is broken or missing
  • Protect from excessive heat (40°C/104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lavender and Rosemary: Beeswax, Camellia Sinensis Leaf Extract*, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract*, Fragrance**, Glycerin, Jojoba Esters, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida (Lavandin) Oil, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Fruit Extract*, Persea Gratissima (Avocado) Fruit Extract*, Propanediol, Saccharomyces Ferment Filtrate, Stearic Acid, Stearyl Alcohol, Water

*Organic ingredient

**Comprised of natural, aromatic, raw materials

Questions or comments?

OTC - QUESTIONS SECTION

Call us at (619) 894-6560

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73088-401-53BYE-BYE CRADLE CAP53 mL in 1 TUBEGEL534

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73088-401BYE-BYE CRADLE CAP (PYRITHIONE ZINC) GEL [TUBBY TODD]4Current NDC, 1 package rows20241215_f4398ad2-7da5-aff0-e053-2995a90ae266.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73088-40173088-401-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
LONICERA JAPONICA FLOWER4465L2WS4YIACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SACCHAROMYCES LYSATER85W246Z1CIACT
ALOE VERA LEAFZY81Z83H0XIACT
CUCUMBERYY7C30VXJTIACT
MANGOI629I3NR86IACT
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
OLIVE OIL6UYK2W1W1EIACT
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)9M44R3409AIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
AVOCADOSDS87L369FIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
BYE-BYE CRADLE CAPPYRITHIONE ZINCTubby Toddf4398ad2-7da5-aff0-e053-2995a90ae2662024-12-12WarningsExact identifier
ndc (package): 73088-401-53
ndc (product): 73088-401
ndc11 (package): 73088040153
spl id: 2918969c-7ba8-9a8d-e063-6394a90a590f
spl set id: f4398ad2-7da5-aff0-e053-2995a90ae266

Reported adverse events (FAERS/openFDA)#

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