PORCELANA NIGHT SKIN LIGHTENING- hydroquinone cream

Porcelana Night Skin Lightening by

Drug Labeling and Warnings

Porcelana Night Skin Lightening by is a Otc medication manufactured, distributed, or labeled by Ultimark Products LLC, Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PORCELANA NIGHT SKIN LIGHTENING 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51545-120
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

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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51545-120-03	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)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	analysis(51545-120) , manufacture(51545-120) , pack(51545-120) , label(51545-120)