PORCELANA NIGHT SKIN LIGHTENING- hydroquinone cream 
Ultimark Products LLC

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.

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Porcelana Night Skin Lightening Cream

Active Ingredient

Hydroquinone U.S.P. 2%

Purpose

Skin Lightener

Uses:

For the gradual fading of dark spots in the skin such as liver and age spots caused by sun exposure, age, acne, pregnancy and the use of oral contraceptives. 

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 many 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, get medical help or contact a Poison Control Center right away.

Questions or Comments?

  • Call toll-free 1-888-681-1840
  • Visit us at www.porcelana.com

Directions

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

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

PORCELANA®
FOR BALANCED SKIN TONE

NIGHT
SKIN LIGHTENING CREAM

FADES DARK SPOTS
      EVENS SKIN TONE
Nourishes With
Moisturizers & Vitamins
      Net Wt 3 oz/85 g

PRINCIPAL DISPLAY PANEL
PORCELANA®
FOR BALANCED SKIN TONE
NIGHT
SKIN LIGHTENING CREAM
FADES DARK SPOTS	EVENS SKIN TONE
Nourishes With
Moisturizers & Vitamins	Net Wt 3 oz/85 g

PORCELANA NIGHT SKIN LIGHTENING 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51545-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
AVOCADO OIL UNSAPONIFIABLES (UNII: UID2HJ7GFT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51545-120-031 in 1 BOX12/14/201708/31/2019
185 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A04/01/201108/31/2019
Labeler - Ultimark Products LLC (964734078)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884analysis(51545-120) , manufacture(51545-120) , pack(51545-120) , label(51545-120)

Revised: 12/2020
 
Ultimark Products LLC