Active Ingredient
Oatmeal 1%
All Purpose Healing Baby Cream
FDA Label NDC 68062-3301
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spa De Soleil for the product All Purpose Healing Baby Cream (NDC 68062-3301). 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, warnings, directions, uses:, inactive ingredients:, warning, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Warnings
For external use only.
When using this product • Avoid contact with eyes. • If contact occurs, rinse thoroughly with water.
Stop using this product and ask a doctor if • condition worsens, or if symptoms last more than 7 days, or if they clear up and occur again within a few days.
Keep out of reach of children. • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Directions
Directions: For mild to moderate eczema on body, apply as needed or as directed by a physician.
Uses:
Uses • Temporarily protects and helps relieve minor skin itching and irritation due to eczema.
Inactive Ingredients:
Inactive ingredients: Aqua, Isopropyl Palmitate, Glycerin, Ricinus Communis (Castor) Seed Oil, Cetyl Alcohol, Polysorbate 20, Helianthus Annuus (Sunflower) Seed Oil, Distearyldimonium Chloride, Avena Sativa (Oat) Kernel Oil, Hydroxyethylcellulose, Panthenol, Hydrogenated Castor Oil, Beeswax, Dimethicone, Copernicia Cerifera (Carnauba) Wax, Sodium Hydroxide, *CO Helianthus Annuus (Sunflower Oil), Tocopheryl Acetate (Vitamin E), Prunus Armeniaca (Apricot) Kernel Oil, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, Gluconolactone, Sodium Benzoate.
*CO Certified Organic
Warning
Keep out of reach of children.
* Please review the disclaimer below.
