Indications For Use
- Lightens dark colorations in the skin such as freckles, age, and liver spots
- Contains a sunscreen to help prevent darkening from re-occurring.
Clear-n-smooth
FDA Label NDC 76445-0399
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hawknad Manufacturing Industries for the product Clear-n-smooth (NDC 76445-0399). 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 indications for use, purpose, dosage, keep out of reach of children, warnings, instructions for use, inactive ingredients, active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Lightening Cream
Dosage
Moisten a cotton ball and apply a thin layer over the entire affected area.
Keep Out Of Reach Of Children
Children under 12 years of age: do not use unless directed by a doctor.
Warnings
Do not use on children under 12 years of age unless directed by a doctor.
This product is not for use for the prevention of sunburn.
When using this product avoid contact with eyes.
Some users of this product may experience a mild skin irritation. If irritation becomes severe, stop use and consult a doctor.
Instructions For Use
Apply a small amount as a thin layer on the affected area twice daily, or use 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. Sun exposure should be limited by using a sunscreen agent, a protective clothing to cover bleached skin after treatment is completed in order to prevent darkening from re-occurring.
Inactive Ingredients
ascorbic acid, cetyl alcohol, citric acid, diazolidinyl urea, dimethicone, disodium EDTA, Fragrance, glyceryl stearate, isopropyl myristate, lanolin alcohol, methyl paraben, propyl paraben, mineral oil, propylene glycol, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, stearyl stearate, tocopherol acetate, glabridin, water.
Active Ingredient
Hydroquinone - 2%
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