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NDC 63742-0025-01 Dr. Lightening Ultra-Potent Facial 20 mg/g Details
Dr. Lightening Ultra-Potent Facial 20 mg/g
Dr. Lightening Ultra-Potent Facial is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Clinical Resolution Laboratory, Inc.. The primary component is HYDROQUINONE.
Product Information
| NDC | 63742-0025 |
|---|---|
| Product ID | 63742-025_87be89b9-81fc-5e5c-e053-2995a90a3f18 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Dr. Lightening Ultra-Potent Facial |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | HYDROQUINONE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/g |
| Substance Name | HYDROQUINONE |
| Labeler Name | Clinical Resolution Laboratory, Inc. |
| Pharmaceutical Class | Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part358A |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 63742-0025-01 (63742002501)
| NDC Package Code | 63742-025-01 |
|---|---|
| Billing NDC | 63742002501 |
| Package | 44 g in 1 TUBE (63742-025-01) |
| Marketing Start Date | 2019-02-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 028c092f-c29d-4e59-8bd3-f5848849fbe9 Details
Warnings:
For external use only
When using this product
- avoid contact with eyes.
- some users of this product may experience mild irritation. If skin irritation becomes severe, stop use and consult a doctor.
- for external use only.
Keep out of reach of children
if swallowed, get medical help or contact a Poison Control Center right away.
Sunburn Alert
The Alpha and Beta Hydroxy Acids (AHA/BHA)in this product may increase sun sensitivity. Wear sunscreen or protective clothing during use to protect against sunburn and for a week afterwards. Continue sun protection after the lightening regimen to avoid UV-induced pigmentations.
Directions
- Adults: apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor.
- Do not use on or around the eye area.
- If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may be noticeable when used on very dark skin.
- Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
Inactive Ingredients
Arbutin, Arginine, Azelaic Acid, Carrageenan, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Cyclopentasiloxane, Dimethyl Isosorbide, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Hydrogenated Polydecene, Isododecane, Kojic Acid, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Purified Water, Salicylic Acid, Sodium Benzoate, Sodium Polyacrylate, Sodium Sulfite, Trideceth-6
INGREDIENTS AND APPEARANCE
| DR. LIGHTENING ULTRA-POTENT FACIAL
hydroquinone cream |
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| Labeler - Clinical Resolution Laboratory, Inc. (825047942) |