Otc - Active Ingredient
Active ingredient Purpose
Hydroquinone 2% Skin lightener
Dark Spot Lightening Cream
FDA Label NDC 56152-4002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Enterprises Ltd. for the product Dark Spot Lightening Cream (NDC 56152-4002). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
Lightens dark (brownish) discolorations in the skin such as: freckles, age and liver spots or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives
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.
Indications & Usage
Stop use and ask a doctor if
- Skin irritation becomes severe or allergic reaction occurs such as hives, itching, or wheezing
Warnings
Warnings
For external use only
Allergy alert: contains sulfites that may cause serious allergic type reactions such as hives, itching, wheezing as severe asthma attack in certain susceptible persons.
Do not use on children under 12 years of age unless directed by a doctor
When using this product
- avoid contact with eyes
- some users may experience a mild skin irritatiion\
Sunburn alert: This product may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for a week afterwards.
If pregnant or breast-feeding, ask a doctor before use.
Dosage & Administration
Directions
- Adults: apply a small amount as a thin layer on the affected area in the evening, or use as directed by a doctor. If no improvement is seen in 3 months of treatment, use of this product should be discontinued. Lightening effect of this product might 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, 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 Ingredient
Water (Aqua), Glycolic Acid, Glyceryl Stearate, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Propanediol, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Phenoxyethanol, Sodium Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Dimethicone, PEG-40 Stearate, Disodium EDTA, Xantan Gum, Allantoin, Ferulic Acid, Ethylhexylglycerin, Dipotassium Glycyrrhizate
Package Label.Principal Display Panel
Dark Spot Lightening Cream
2% Hydroquinone
6% Glycolic Acid
1.7 FL OZ 50mL
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