Porcelana 24 Hour Skin Lightening
FDA Label NDC 61543-0000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cca Industries Inc. for the product Porcelana 24 Hour Skin Lightening (NDC 61543-0000). 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 active ingredient, purpose, uses:, warnings, do not use, when using this product, stop use and ask a doctor, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydroquinone U.S.P. 2%

Octyl methoxycinnamate 2.5%

Purpose

Skin Lightener

Sun Screen

Uses:

For the gradual fading of dark spots in the skin such as age liver spots and pigment in the skin that may occur in pregnancy or from the use of oralcontraceptives. Contains a sunscreen to help prevent darkening from reoccurring.

Warnings

For External use only. Avoid contact with eyes. 

Do Not Use

on children under 12 years of age unless directed by a doctor.

When Using This Product

some users may experience a mild skin irritation.

Stop Use And Ask A Doctor

if skin irritation becomes severe.

Keep Out Of The Reach Of Children.

If swallowed, seek medical help or contact a Poison Control Center right away.

This product is not for use in the prevention of sunburn,

Sun exposure should be limited by using a sunscreen agent: a sun blocking agent or protective clothing to cover bleached skin after treatment is completed to prevent darkening from reoccurring.

Directions

Adults apply a small amount as a thin layer on the affected area(s) as part of your daily routine or as directed by a doctor. If no improvement is seen after three months of treatment, use of this product should be discontinued. 

Other Information

  • Lightening effect of this product may not be noticeable when used on very dark skin.

Inactive Ingredients

Water, Mineral Oil, Glyceryl Stearate, Cetyl Alcohol, Isopropyl Palmitate, PEG-100 Stearate, Propylene Glycol, Emulsifying Wax NF, Stearic Acid, Hydroxyethylcellulose, Disodium EDTA, Sodium Metabisulfite, Fragrance, Diazolidinyl Urea, Methylparaben, Propylparaben, BHT, Tocopheryl (Vitamin E) Acetate, Beta-Carotene, Magnesium Ascorbyl Phosphate, Citric Acid.

Questions Or Comments?

  • Call toll-free:1-800-595-6230
  • Visit us at www.porcelana.com

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