ESOTÉRICA® FADE CREAM NIGHT TIMEWith Moisturizers

Esoterica by

Drug Labeling and Warnings

Esoterica by is a Otc medication manufactured, distributed, or labeled by Medicis Pharmaceutical Corp, Contract Pharmaceutical Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ESOTERICA NIGHTTIME WITH MOISTURIZERS- hydroquinone cream 
Medicis Pharmaceutical Corp

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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ESOTÉRICA®
FADE CREAM
NIGHT TIME
With Moisturizers

Drug Facts

Active ingredients

Hydroquinone USP 2%

Purpose

Skin Lightener

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 contraceptives.

Warnings

For external use only.

Do not use

  • On inflamed or broken skin
  • 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.

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 stearate, isopropyl palmitate NF, light mineral oil NF, ozokerite, propylene glycol USP, stearyl alcohol NF, PEG-1500 stearate, poloxamer 188, propylene glycol monostearate NF, steareth-20, laureth-23, sodium metabisulfite NF, sodium lauryl sulfate NF, anhydrous citric acid USP, fragrance, methylparaben NF, dimethicone, 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 - 70 g Carton

Skin Lightener with Moisturizers
NDC # 99207-290-02

E
ESOTÉRICA®

ESOTÉRICA®
FADE CREAM

NIGHTTIME
With Moisturizers

Net Wt.
2.5 oz (70 g)

carton.jpg
ESOTERICA  NIGHTTIME WITH MOISTURIZERS
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 99207-290
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydroquinone (UNII: XV74C1N1AE) (hydroquinone - UNII:XV74C1N1AE) hydroquinone20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
glyceryl monostearate (UNII: 230OU9XXE4)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
mineral oil (UNII: T5L8T28FGP)  
ceresin (UNII: Q1LS2UJO3A)  
propylene glycol (UNII: 6DC9Q167V3)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
polyethylene glycol 1500 (UNII: 1212Z7S33A)  
poloxamer 188 (UNII: LQA7B6G8JG)  
steareth-20 (UNII: L0Q8IK9E08)  
laureth-23 (UNII: N72LMW566G)  
sodium metabisulfite (UNII: 4VON5FNS3C)  
sodium lauryl sulfate (UNII: 368GB5141J)  
anhydrous citric acid (UNII: XF417D3PSL)  
methylparaben (UNII: A2I8C7HI9T)  
dimethicone (UNII: 92RU3N3Y1O)  
propylparaben (UNII: Z8IX2SC1OH)  
edetate disodium (UNII: 7FLD91C86K)  
butylated hydroxyanisole (UNII: REK4960K2U)  
PROPYLENE GLYCOL MONOPALMITOSTEARATE (UNII: F76354LMGR)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 99207-290-021 in 1 CARTON06/01/200501/31/2020
170 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 finalpart358A06/01/200501/31/2020
Labeler - Medicis Pharmaceutical Corp (182837492)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmaceutical Limited248761249MANUFACTURE(99207-290)

Revised: 9/2011
 
Medicis Pharmaceutical Corp