Tubby Todd - Bye-Bye Cradle Cap (73088-401)

BYE-BYE CRADLE CAP by

Drug Labeling and Warnings

BYE-BYE CRADLE CAP by is a Otc medication manufactured, distributed, or labeled by Tubby Todd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BYE-BYE CRADLE CAP- pyrithione zinc gel 
Tubby Todd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Tubby Todd - Bye-Bye Cradle Cap (73088-401)

Active Ingredients

PYRITHIONE ZINC 0.95%

Purpose

SEBORRHEIC DERMATITIS

Uses

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

Warnings

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.

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

Directions

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

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

Inactive ingredients

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?

Call us at (619) 894-6560

BYE-BYE CRADLE CAP 
pyrithione zinc gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73088-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.95 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)	Â
WATER (UNII: 059QF0KO0R)	Â
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	Â
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)	Â
ALOE VERA LEAF (UNII: ZY81Z83H0X)	Â
CUCUMBER (UNII: YY7C30VXJT)	Â
MANGO (UNII: I629I3NR86)	Â
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)	Â
OLIVE OIL (UNII: 6UYK2W1W1E)	Â
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)	Â
GREEN TEA LEAF (UNII: W2ZU1RY8B0)	Â
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)	Â
XANTHAN GUM (UNII: TTV12P4NEE)	Â
GLYCERIN (UNII: PDC6A3C0OX)	Â
AVOCADO (UNII: SDS87L369F)	Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73088-401-53	53 mL in 1 TUBE; Type 0: Not a Combination Product	02/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M032	04/20/2021

Labeler - Tubby Todd (052545299)

Revised: 2/2023

Document Id: f4398abb-8290-7b54-e053-2995a90a71de

34390-5

Set id: f4398ad2-7da5-aff0-e053-2995a90ae266

Version: 1

Effective Time: 20230208

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