Warnings
Stop use and ask a Doctor if rash occurs
- For external use only.
- Do no use on damaged or broken skin
- Stop use and ask a doctor if rash occurs
- Avoid the product from entering your eyes
- Children under 6 months Ask a Doctor
Melano Out Cream
FDA Label NDC 70663-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meso System S.a. for the product Melano Out Cream (NDC 70663-007). 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 warnings, uses, otc - keep out of reach of children, directions, questions or comments ?, active ingredients, inactive ingredients, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- Cream formulated to atenuate and eliminate the coetaneus spot of melanic origin located at the epidermic level
Otc - Keep Out Of Reach Of Children
- Keep out of the reach of chuldren.
- In case of overdose get medical help or Contact a Poison Control Center right away.
Directions
- Clean the skin thoroughly before applying the cream.
- Cover the entire affected area with a thin layer. First week apply three times daily (morning-afternoon-night). Second week apply two times daily (morning-night). Third week apply once a day for one year.
- During summer it is recommended the application of the cream after sun exposure. If bothersome dryness or peeling occurs, reduce application to once a day or every other day
Questions Or Comments ?
- +35 1227347125 M-F: 9:00 am to 5:00 pm
Active Ingredients
Active Ingredients Purpose
Allantoin 0.01%................................Skin Protectant
Glycerin 0.25%.................................Skin Protectant
Inactive Ingredients
Water, Azelaic Acid, Mineral Oil, Ethylhexyl Methoxycinnamate, Cetearyl Alcohol, Salicylic Acid, Kojic Acid,,Arbutin, Phenoxyethanol, Glycyrrhetinic Acid, Citric Acid, Lactic Acid, Phytic Acid, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Ascorbic Acid, Sodium, Lactate, Serine, Sorbitol, Tea-lactate, Urea, Ethylhexylglycerin, Sodium Chloride
Box (Melano Out Crema Usa)
Indications & Usage
- Cream formulated to atenuate and eliminate the coetaneus spot of melanic origin located at the epidermic level
Melano Out Cream
Melano Out Cream
Skin Protecting
Cream (P Cx 0042 Melanoout Cream R2)
* Please review the disclaimer below.
