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Esoterica

Medicis Pharmaceutical Corp

ESOTÉRICA FADE CREAM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients: Purpose:
Hydroquinone USP 2% Skin Lightener
Oxybenzone USP 2.5% Sunscreen
Padimate O USP 3.3% Sunscreen

Use

Lightens dark (brownish) areas on the skin such as freckles, age and liver spots, pigment in skin that may occur in pregnancy or from the use of oral contraceptions. Contains a sunscreen to help prevent darkening from reoccurring.

Warnings

For external use only.

Do not use

  • On inflamed or broken skin
  • For prevention of sunburn
  • As sunscreen
  • On children under 12 years of age unless directed by a physician

Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid

When using this product

  • Avoid contact with eyes
  • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor
  • Limit sun exposure

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

Directions

Adults

  • Apply a small amount as a thin layer to affected areas twice daily or as directed by a doctor
  • For sensitive skin, test overnight on small area (inside elbow)
  • If no improvement is seen after 3 months of treatment, discontinue use. On very dark skin, lightening effect may not be noticeable
  • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Esoterica Other information

  • Store at room temperature
  • Tamper-evident carton
  • Serious side effects may be reported to the phone number provided in the Questions? section below.

Inactive ingredients

purified water USP, glyceryl monostearate, isopropyl palmitate NF, ozokerite wax, mineral oil light NF, stearyl alcohol NF, PEG 1500 monostearate, poloxamer 188, propylene glycol USP, steareth-20, laureth-23, allantoin ascorbate, sodium bisulfite NF, steareth-10, dimethicone, sodium lauryl sulfate NF, methylparaben NF, fragrance, propylparaben NF, edetate disodium, butylated hydroxyanisole

Questions?

1-800-900-6389 (24 hours a day, 7 days a week)

Distributed by:
MEDICIS
The Dermatology Company®

Scottsdale, AZ 85256

PRINCIPAL DISPLAY PANEL - 70g Carton

Skin Lightener with Sunscreen
NDC # 99207-292-02

E
ESOTÉRICA ®

ESOTÉRICA®
FADE CREAM

DAYTIME
With Sunscreen

Net Wt.
2.5 oz (70g)

Esoterica

Esoterica

hydroquinone, oxybenzone, and padimate o CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:99207-292
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Hydroquinone HYDROQUINONE 20 mg
OXYBENZONE OXYBENZONE 25 mg
PADIMATE O PADIMATE O 33 mg

Inactive Ingredients

Ingredient Name Strength
water
GLYCERYL MONOSTEARATE
ISOPROPYL PALMITATE
Ceresin
Mineral Oil
stearyl alcohol
POLYETHYLENE GLYCOL 1500
POLOXAMER 188
propylene glycol
Steareth-20
laureth-23
ALLANTOIN
SODIUM BISULFITE
STEARETH-10
DIMETHICONE
SODIUM LAURYL SULFATE
METHYLPARABEN
PROPYLPARABEN
EDETATE DISODIUM
BUTYLATED HYDROXYANISOLE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 70 in 1 JAR
2 NDC:99207-292-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part358A 2005-06-01


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