Drug Facts
Drug Facts
Baby Diaper Rash Cream
FDA Label NDC 73418-301
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hello Bello for the product Baby Diaper Rash Cream (NDC 73418-301). 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, active ingredients, purpose, uses, warnings, when using this product,, stop use and ask a doctor, 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
Active Ingredients
Zinc Oxide - 40%
Purpose
Skin Protectant
Uses
- Helps treat and prevent diaper rash
- Protects chafed skin due to diaper rash and helps seal out wetness
Warnings
For external use only
When Using This Product,
do not get into eyes
Stop Use And Ask A Doctor
if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- Change wet and soiled diapers promptly.
- Cleanse the diaper area and allow to dry.
- Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
- Do not use if quality seal is broken
- Do not store above 40C (104F)
Inactive Ingredients
Sunflower Seed Oil, Castor Seed Oil, Cera Alba (Beeswax), Cocos Nucifera Oil, Simmondsia Chinensis (Jojoba) Oil, Shea Butter, Tocopherol, Citric Acid
* Please review the disclaimer below.
