Label: PORCELANA DAY SKIN LIGHTENING- hydroquinone and octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51545-110-03 - Packager: Ultimark Products LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 14, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses:
- Warnings
- Do Not use on
- Keep out of the reach of children.
- Questions or Comments?
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Directions
- Adults: 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.
- 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 after treatment is completed in order to prevent darkening from reoccurring.
- Adults: 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.
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Inactive Ingredients
Water, Mineral Oil, Glyceryl Stearate, Cetyl Alcohol, Isopropyl Palmitate, PEG-100 Stearate, Propylene Glycol, Emulsifying Wax NF, Stearic Acid, Hydroxyethylcellulose, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Beta-Carotene, Disodium EDTA, C13-14 Isoparaffin, Sodium Meta-Bisulfite, Citric Acid, BHT, Methylparaben, Propylparaben, Diazolidinyl Urea, Fragrance.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PORCELANA DAY SKIN LIGHTENING
hydroquinone and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51545-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 0.02 g in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.025 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) .BETA.-CAROTENE (UNII: 01YAE03M7J) EDETATE DISODIUM (UNII: 7FLD91C86K) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) SODIUM METABISULFITE (UNII: 4VON5FNS3C) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51545-110-03 1 in 1 BOX 12/14/2017 1 85 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 04/01/2011 Labeler - Ultimark Products LLC (964734078) Registrant - Humco Holding Group, Inc. (825672884)
