Forms And Presentation
Cream: Tube of 30 g.
Derma Lightening
FDA Label NDC 82160-412
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pella Pharmaceuticals Co. Ltd for the product Derma Lightening (NDC 82160-412). 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 forms and presentation, active ingredients, inactive ingredients, purpose, properties, indications, precaution, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Hydroquinone 2%
Tretinoin 0.025%
Inactive Ingredients
Aqua, Glycerin, Cetyl Alcohol, Ceteareth- 25, Cetearyl Alcohol, Caprylic / Capric Triglyceride, Dimethicone, Stearic Acid, Petrolatum, Benzyl Alcohol, Sodium Lauryl Sulphate, Potassium Sorbate, Sodium Metabisulfite, Parfum and BHA
Purpose
Lightening Cream
Properties
Night cream that lightens and moisturizes the skin.
Paraben free.
Indications
Whitening of skin.
Reduction of spots due to sunlight exposure.
Pregnancy Mask (Melasma). (Use after pregnancy)
Reduction of secular pigmentations of acne.
Can be used on knees and elbows.
Precaution
keep out of reach of children
Warnings
- For external use only
- Avoid contact with eyes
- Do not expose to sunlight and wear protective clothing
Contraindications
Hypersensitivity to any of the components.
Side Effects
There are no known side effects.
Dosage And Administration
Apply the cream once daily at night after cleansing. Then rub it gently.
Storage Conditions
Store at a temperature be]ow 30 °C.
Do not store after a month from opening the tube.
* Please review the disclaimer below.
