Listing For Clear-n-smooth Plus Skin Lightening Cream

Listing For Clear-n-smooth Plus Skin Lightening Cream
SPL v3
SPL
SPL Set ID 783cd3af-939c-0f74-e053-2991aa0a2c57
Route
TOPICAL
Published
Effective Date 2018-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydroquinone (8.1 g)
Inactive Ingredients
Glyceryl Monostearate Sodium Lauryl Sulfate Stearyl Stearate Stearyl Alcohol Cetyl Alcohol Isopropyl Myristate Dimethicone 350 .alpha.-tocopherol Acetate Octinoxate Light Mineral Oil Ethylhexyl Palmitate Peg-100 Stearate Ascorbic Acid Anhydrous Citric Acid Bisulfite Ion Methylparaben Propylparaben Diazolidinyl Urea Water Propylene Glycol Edetate Disodium Glabridin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1992-01-02

Description

Lightens dark colorations in the skin such as freckles, age, and liver spots Contains a sunscreen to help prevent darkening from re-occurring.

Purpose

Skin Lightening Cream


Medication Information

Purpose

Skin Lightening Cream

Description

Lightens dark colorations in the skin such as freckles, age, and liver spots Contains a sunscreen to help prevent darkening from re-occurring.

Dosage

Moisten a cotton ball and apply a thin layer over the entire affected area.

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.

Active Ingredient

Hydroquinone - 2%

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.
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.

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.

Principal Display Panel

Keep Out of Reach of Children

Children under 12 years of age: do not use unless directed by a doctor.


Structured Label Content

Dosage

Moisten a cotton ball and apply a thin layer over the entire affected area.

Purpose

Skin Lightening Cream

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.

Active Ingredient

Hydroquinone - 2%

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.
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.

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.

Principal Display Panel

Keep Out of Reach of Children

Children under 12 years of age: do not use unless directed by a doctor.


Advanced Ingredient Data


Raw Label Data

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