Active Ingredient
Colloidal Oatmeal 1.0%
Skin Protectant
FDA Label NDC 69123-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elaj, Llc for the product Skin Protectant (NDC 69123-111). 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 a 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
Temporarily protects and helps relieve minor skin irritations and itching due to eczema
Warnings
For external use only
When Using This Product
Do not get into eyes
Stop Use And Ask A Doctor If
- Condition worsens
- Symptoms last more than 7 days or clear 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
- Apply as needed or recommended 3-4 x a day initially during flare up and as needed after flareup begins to subside
- Apply generously before bed to help avoid itching while sleeping
Storage
Store at room temperature
Inactive Ingredients
USP White Petrolatum, Lemon Concentrate, Glycerin, Honey, Prunus Amygdalus Dulcis (Almond Oil), Alpha tocopherol (Vitamin E), Beeswax, Soy Wax, Talc, Boric acid, Zinc oxide, Stearic acid, Pistachia lenticus (Mastica), Vanilla
Questions Or Comments
1-844-Buy-ELAJ (949-581-1200) or visit www.elajnaturally.com
Product Packaging Labels
57 g, 113 g, and 227 g Box Labels
57 G, 113 G, And 227 G Container Labels (Elaj Label)
57 g, 113 g, and 227 g Container Labels
* Please review the disclaimer below.
