FDA Label for Dark Spot Lightening Cream
View Indications, Usage & Precautions
Dark Spot Lightening Cream Product Label
The following document was submitted to the FDA by the labeler of this product Cosmetic Enterprises Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient Purpose
Hydroquinone 2% Skin lightener
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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