Drug Facts
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Baby Bum Diaper Cream
FDA Label NDC 74028-149
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Creative Consumer Products, Inc. Dba (doing Business As) Dionis Goat Milk Skincare for the product Baby Bum Diaper (NDC 74028-149). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient Zinc Oxide 20.5%
Otc - Purpose
Purpose................Skin Protectant
Indications & Usage
Uses Helps prevent and relieve diaper rash. Protects against wetness and irritants.
Warnings
Warnings For external use only.
Otc - When Using
When using this product Avoid contact with eyes.
Otc - Stop Use
Stop use and contact a doctor if conditions worsen or persist for more than seven days, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
Dosage & Administration
Directions Change wet and soiled
diapers promptly. Cleanse the diaper area
thoroughly and allow it to dry. Apply a thick
layer of cream to the entire diaper area,
especially on areas prone to rash. Use at
every diaper change, especially at bedtime or
when prolonged exposure to wetness is
expected. For best results, use daily to help
protect and soothe the skin.
Other Information
Store between 68° to 77° F. Do not use if seal is broken.
Inactive Ingredient
Inactive ingredients Helianthus Annuus
(Sunflower) Seed Oil, Ricinus Communis
(Castor) Seed Oil, Synthetic Beeswax, C12-15
Alkyl Benzoate, Butyrospermum Parkii (Shea)
Butter, Cocos Nucifera (Coconut) Oil, Water
(Aqua), Polyglyceryl-3 Polyricinoleate, Goat
Milk, Glyceryl Caprylate, Cetearyl Olivate,
Hydrogenated Castor Oil, Sorbitan Olivate,
Copernicia Cerifera (Carnauba) Wax,
Ethylhexylglycerin, Glyceryl Behenate/
Eicosadioate, Glyceryl Undecylenate,
Propanediol, 1,2-Hexanediol,
Caprylhydroxamic Acid
Otc - Questions
Questions or comments?
Call 1-800-566-7627
Package Label.Principal Display Panel
Dionis Goat Milk Skincare -
made with goat milk
BABY BUM
DIAPER CREAM
prevents, treats, and
soothes diaper rash
safe for sensitive skin
pediatrician and
dermatologist approved
NET WT. 2.5 OZ / 71 G
Made for DIONIS® Warrington, PA 18976
(800) 566-7627
MADE IN USA with globally
sourced components
* Please review the disclaimer below.
