Pharmaskincare Parfait Lightening Serum: Package Insert and Label Information

PHARMASKINCARE PARFAIT LIGHTENING SERUM- hydroquinone lotion
Spa de Soleil

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.

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, Caprylic/Capric Triglyceride, Glycerin, C12-15 Alkyl Benzoate, Cetyl Alcohol, Dimethicone, Glyceryl Stearate SE, Jojoba Esters, Polyglyceryl-3 Beeswax, Polyglyceryl-6 Distearate, Sodium Metabisulfite, Carbomer, Peg-4, Kojic Acid, Lactic Acid, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Arctostaphylos Uva-Ursi Leaf Extract, BHT, Sodium Hydroxide, Ginkgo Biloba Leaf Extract, Diospyros Kaki Fruit Extract, Betula Alba Bark Extract, Ruscus Aculeatus Root Extract, Hydrolyzed Soy Protein, Arbutin, Thioctic Acid, Ubiquinone, Retinol, Polysorbate 20, BHA, Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Fragrance, Dehydroacetic Acid

Warning

Keep out of reach of children.

Pharmaskincare BrighteningParfaitSerum.jpg

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PHARMASKINCARE PARFAIT LIGHTENING SERUM
hydroquinone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68062-9104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 0.05 mg in 2.5 mL
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
WATER
CETYL ALCOHOL
ALKYL (C12-15) BENZOATE
CYCLOMETHICONE 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68062-9104-1 15 mL in 1 BOTTLE, DISPENSING None
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 Operations
Spa de Soleil 874682867 manufacture (68062-9104)

Revised: 10/2017 Spa de Soleil

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