Active Ingredients
Colloidal oatmeal 1%
Renew Intensive Skin Therapy Cream
FDA Label NDC 54473-410
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca Inc. for the product Renew Intensive Skin Therapy (NDC 54473-410). 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 ingredients, 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
Purpose
Skin protectant
Indications & Usage
Uses Temporarily protects and helps relieve minor skin irritation and itching due to:
- rashes
- eczema
Warnings
For external use only
Otc - When Using
When using this product avoid contact with 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
- apply as needed or as directed by a doctor
- for children under 2 years of age: ask a doctor
Other Safety Information
Other information
- for mild to moderate eczema
- store below 86 F (30 C)
Inactive Ingredient
water, glycerin, petrolatum, distearyldimonium chloride, isopropyl palmitate, cetyl alcohol, allantoin, benzyl alcohol, citric acid
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