Otc - Active Ingredient
Active Ingredients Purpose
Zinc Oxide 10% Skin Protectant
Earth Baby Diaper Rash Cream
FDA Label NDC 62588-904
Full FDA labeling including 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, dosage & administration, inactive ingredient, 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 - Purpose
Uses:
Helps protect against diaper rash and irritation.
Warnings
For external use only
Otc - When Using
When using this product
Keep out of eyes
Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash or irritation develops and lasts or does not improve within 7 days. This may be the sign of a serious condition.
Dosage & Administration
Directions:
Change Diaper promptly. Clean diaper area, allow to dry. Apply a generous amount of cream with each diaper change and before bedtime.
Inactive Ingredient
Inactive Ingredients: Avena SAtiva (Oat) Kernel Protein, Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes/Seed Oil, Corn Starch, Fragrance containing Chamomile Oil, Lavender Oil and Vanilla, 1,2-Hexanediol, Jojoba Oil, Petrolatum, Potassium Jojobate, Rosmarinus Officinalis (Rosemary) Flower/Leaf/Stem Extract, Water, Fragaria Vesca (Strawberry) Fruit Extract (Fresh Cells).
Otc - Keep Out Of Reach Of Children
Like all drugs, keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately..
* Please review the disclaimer below.
