Otc - Active Ingredient
Active Ingredient
Zinc Oxide 40%
Earth Baby Diaper Rash Cream
FDA Label NDC 62588-904
11 label sections · Submitted to the FDA by Earth Baby, Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Earth Baby, Inc for the product Earth Baby Diaper Rash Cream (NDC 62588-904). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Warnings
Warnings
For external use only.
Otc - When Using
When using this product Do not get into eyes
Otc - Stop Use
Stop use and ask a doctor if
Condition worsens.
Symptoms last more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Change diaper promptly.
Clean diaper area, allow to dry
Apply a generous amount of creamwith each diaper change and before bedtime.
Other Safety Information
Other information
Store at 20° - 25°C (68° to 77°F)
Inactive Ingredient
Inactive ingredients:
Avena Sativa (Oat) Kernel Protein, Aloe Barbadensis Leaf Juice*, Aqua/Water, Beeswax, Canola Oil, Carthamus Tinctorius (Safflower) Oleosomes*, Caryodendron Orinocense (Kahai) Seed Oil, Cucurbita Pepo (Pumpkin) Extract, Glycerin, Lavandula Intermedia (Lavender) Flower/Leaf/Stem Extract*, Locinera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Extract, Parfum/Natural Fragrance, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E), Zea Mays (Corn) Starch.
Indications & Usage
Helps protect against diaper rash and irritation.
Package Label.Principal Display Panel
Drc (Drc)
* Please review the disclaimer below.
