Indications and uses
Ÿ• ŸFŸor the gradual fading of dark (brownish) skin discolorations such as freckles, age and liver spots or uneven pigment that may occur due to sun overexposure, pregnancy or from the use of oral contraceptives.
Dermisa
- Manufacturer
- Montani Cosmetics Inc
- Effective date
- 2018-07-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:56:22
Label at a glance#
ProductDermisa Skin Fade Vitamin C infused
Active ingredientHYDROQUINONE
Label structure11 sections
Dosage and administration
• Adults Apply a small amount as a thin layer to the affected areas twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.Lightening effect of this product may not be noticeable when used on very dark skin. • Children under 12 years of age Do not use unless directed by a doctor • Sun exposure should be limited by using a sunscreen ...
Label contents#
Full prescribing information#
Active Ingredient
Hydroquinone USP 2%
Octyl Dimethyl Paba 0.60%
Purpose
Skin Lightener
Uses
Ÿ• ŸFŸor the gradual fading of dark (brownish) skin discolorations such as freckles, age and liver spots or uneven pigment that may occur due to sun overexposure, pregnancy or from the use of oral contraceptives.
Warnings
For external use only
Do not use
• On children under 12 years of age unless directed by a doctor • This product is not for use in the prevention of sunburn • On inflamed or broken skin
When using this product
• Avoid contact with the eyes • Some users of this product may experience a mild skin irritation, if skin irritation becomes severe stop use and consult a doctor
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
• Adults Apply a small amount as a thin layer to the affected areas twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.Lightening effect of this product may not be noticeable when used on very dark skin. • Children under 12 years of age Do not use unless directed by a doctor
• Sun exposure should be limited by using a sunscreen agent, or protective clothing to prevent bleached skin after treatment completed to prevent darkening from recurring
Other Information
• Store at room temperature • Tamper-evident tube • Contact us at contractar en info@dermisa.com
Inactive ingredients
Water (Aqua), Glycerin, Paraffinum Liquidum (Mineral Oil), Stearyl Alcohol, Petrolatum, Cetearyl Alcohol, Steareth-10, Propylene Glycol, Steareth-2, Sodium Sulfite, Citric Acid, Sodium Metabisulphate, Diazolidinyl Urea, Dicetyl Phosphate, Ceteth-10 Phosphate, Fragrance (Parfum), Methylparaben, Propylparaben, Ethylhexyl Methoxyinnamate, Limonene, Hydroxycitronellol, Ascorbic Acid (Vitamin C)
Package Label
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROQUINONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 85490a6b-2306-6bf2-c51b-eb63537dc2da | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68343-005-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0e65-a910-e053-dadaa90a0b85 | Drug Facts |
| 68343-005-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-0e65-a910-e053-dadaa90a0b85 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68343-005-01 | DermisaSkin Fade Vitamin C infused | 1 in 1 BOX | CREAM | 1 | 1 | |
| 68343-005-02 | DermisaSkin Fade Vitamin C infused | 1 in 1 BOX | CREAM | 1 | 1 | |
| 68343-005-25 | DermisaSkin Fade Vitamin C infused | 25 g in 1 TUBE | CREAM | 25 | 1 | |
| 68343-005-50 | DermisaSkin Fade Vitamin C infused | 50 g in 1 TUBE | CREAM | 50 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Dermisa Skin Fade Vitamin C infused
- Hydroquinone
- DIHEXADECYL PHOSPHATE
- CITRIC ACID MONOHYDRATE
- LIMONENE, (+)-
- SODIUM SULFITE
- SULFITE ION
- DIAZOLIDINYL UREA
- OCTINOXATE
- HYDROXYCITRONELLOL
- PROPYLENE GLYCOL
- WATER
- MINERAL OIL
- GLYCERIN
- STEARYL ALCOHOL
- PETROLATUM
- STEARETH-10
- STEARETH-2
- ASCORBIC ACID
- SODIUM METABISULFITE
- PROPYLPARABEN
- METHYLPARABEN
- CETOSTEARYL ALCOHOL
- CETETH-10 PHOSPHATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68343-005 | 68343-005-50, 68343-005-01, 68343-005-25, 68343-005-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 714de9d8-ce2b-2274-e053-2995a90afdb0 | 714de9d8-ce31-2274-e053-2995a90afdb0 | 2018-07-18 | Warnings | 714de9d8-ce2b-2274-e053-2995a90afdb0 714de9d8-ce31-2274-e053-2995a90afdb0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.