Active Ingredient
Zinc Oxide 25%
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash Cream
FDA Label NDC 79265-8580
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Babo Botanicals, Inc. for the product Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash (NDC 79265-8580). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
- Helps treat and prevent diaper rash
- Protects minor skin irritation associated with diaper rash
- Helps seal out wetness
Warnings
For external use only
When Using This Product
- do not get into eyes
Stop Use And Ask Doctor If
- condition worsens
- 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 immediately.
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, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Other Information
- Protect this product from excessive heat and direct sun
- May stain some fabrics and surfaces
Inactive Ingredients
Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Cocos Nucifera (Coconut) Oil*, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Vegetable Oil, Lecithin, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Rosmarinus Officinalis (Rosemary) Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Theobroma Cacao (Cocoa) Seed Butter*
*CERTIFIED ORGANIC INGREDIENTS
Questions Or Comments?
Call 1-800-422-2987 M-F 9:00AM-5:00PM EST
Product Packaging
1 (79265 8580)
* Please review the disclaimer below.
