Otc - Active Ingredient
Colloidal Oatmeal 0.5%
Atopis Eczema Therapy Cream
FDA Label NDC 71570-001
12 label sections · Submitted to the FDA by Bionona Limited · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionona Limited for the product Atopis Eczema Therapy Cream (NDC 71570-001). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Colloidal Oatmeal 0.5%...... Skin Protectant
Indications & Usage
temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema • insect bites
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
Apply twice daily for best results.
Storage And Handling
• Safe for the face and body.
• External use only. If irritation should occur discontinue use.
• When using this product you may notice a slight tingling sensation; this is normal and will subside.
• Do not use if quality seal is broken or missing.
Inactive Ingredient
Myriphytase extract (Cocos nucifera (coconut) water, Bee pollen, Cocos nucifera coconut) oil, Notofagus fuca honeydew), Cetearyl olivate, Sorbitan olivate, Carthamus tinctorius (Safflower) seed oil, Cetearyl alcohol, Glycerin, Macadamia ternifolia seed oil, Butyrospermum parkii (shea butter), Tocopheryl acetate, Sodium stearoyl glutamate, benzyl alcohol, dehydracetic acid, Citrus aurantium bergamia (bergamot) fruit oil, Xanthan gum, Citric acid.
Otc - Questions
(855) 969-5002 or [email protected]
Package Label.Principal Display Panel
ATOPIS
Eczema
Therapy Cream
Skin Protectant
Cream for eczema, rash and insect bite relief
Clinically shown to relieve and protect dry, itchy, irritated skin, due to eczema
• Soothes, nourishes and restores moisture
• No parabens, no solvents, no artificial fragrances
• Clinically trialed on humans, not tested on animals
Product of New Zealand
E Net Wt 2.6 oz/75g
Atopis (Atopis)
* Please review the disclaimer below.
