PHARMASKINCARE SERUM SKIN LIGHTENING- hydroquinone lotion

Pharmaskincare Serum Skin Lightening by

Drug Labeling and Warnings

Pharmaskincare Serum Skin Lightening by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Warnings

• For external use only. Do not use on inflamed or broken skin.
• When using this product avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
• Avoid unnecessary sun exposure and use a sunscreen or protective clothing.
• Stop use and consult a doctor if irritation develops or no improvement is seen after three months of use.
• If pregnant or breast feeding, consult a physician before use.
• Keep out of reach of children.

Directions

Adults: Apply twice daily onto affected area after thorough cleansing or as directed by a doctor. Not recommended for use on children under 12 years of age. For children under age 12: ask a physician before use.

Uses:

Treatment against hyperpigmentation and age spots.

Inactive Ingredients:

Water, SD Alcohol 40-B, Glycerin, Hydroxyethylcellulose, Polysorbate 20, Arbutin, PEG-40 Hydrogenated Castor Oil, Sodium Metabisulfite, Panthenol, Kojic Acid, Peg-4, Glycyrrhiza Glabra (Licorice) Root Extract, Lactic Acid, Morus Alba Root Extract, Arctostaphylos Uva-Ursi Leaf Extract, Butylene Glycol, Sodium Hydroxide, BHT, Ginkgo Biloba Leaf Extract, Ruscus Aculeatus Root Extract, Diospyros Kaki Fruit Extract, Betula Alba Bark Extract, Glycolic Acid, *CO Glycerin, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Dehydroacetic Acid, Fragrance

Warning

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

Pharmaskincare BrighteningSerumSkinLightening.jpg

INGREDIENTS AND APPEARANCE

PHARMASKINCARE SERUM SKIN LIGHTENING 
hydroquinone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	0.05 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9105-1	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	10/10/2017

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-9105)