EXUVIANCE INTENSE LIGHTENING COMPLEX- hydroquinone gel 
NeoStrata Company Inc

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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Exuviance®
Intense
Lightening Complex

Drug Facts

Active Ingredient

Hydroquinone 2.0%

Purpose

lightening agent

Uses

  • lightens discolored skin such as freckles, age and liver spots or pigment in the skin that may occur from pregnancy or from the use of oral contraceptives

Warnings

For external use only

  • Some users may develop a mild skin irritation.

When using this product

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • Rash or skin irritation develops and becomes severe.

Ask a doctor before use

  • On children under 12 years of age.
  • If you are pregnant, breastfeeding or intend to become pregnant within 3 months of use.

Keep out of reach of children

  • If swallowed, get medical help or contact a poison control center right away.

Directions

  • Apply a thin layer on affected area twice daily or as directed by a doctor.
  • If no improvement is seen after 3 months treatment, discontinue use.
  • Lightening effect may not be noticeable when used on very dark skin.
  • Limit sun exposure during and after use to prevent darkening from recurring.
  • Use a sunblocking agent or protective clothing.

Other Information

Store at 15°C-30°C (59°F-86°F)

Inactive Ingredients

Alcohol Denat., Aqua (Water), Arginine, BHT, CI 17200 (Red 33), CI 19140 (Yellow 5), Citric Acid, Gluconolactone, Glycyrrhiza Glabra (Licorice) Extract, Kojic Acid, Lactobionic Acid, Oxalic Acid, Polyquaternium-10, Potassium Hydroxide, Propylene Glycol, Sodium Bisulfite, Sodium Sulfite.

PRINCIPAL DISPLAY PANEL - 30 g Carton

DERMATOLOGIST DEVELOPED
Exuviance®

Intense
Lightening Complex

targeted treatment

Skin Lightener Gel
2% Hydroquinone

Kojic Acid and botanical
Licorice amplify Hydroquinone
to fade and diminish age spots

PHA exfoliates to break up
pigmentation and helps
prevent new spots

Net Wt 1.0 oz / 30 g

Principal Display Panel - 30 g Carton
EXUVIANCE INTENSE LIGHTENING COMPLEX 
hydroquinone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-8750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
ARGININE (UNII: 94ZLA3W45F)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
KOJIC ACID (UNII: 6K23F1TT52)  
LACTOBIONIC ACID (UNII: 65R938S4DV)  
OXALIC ACID (UNII: 9E7R5L6H31)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58414-8750-11 in 1 CARTON02/22/201101/19/2017
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A02/22/201101/19/2017
Labeler - NeoStrata Company Inc (605754829)

Revised: 1/2017
Document Id: 6034dcc4-7742-4f96-b99f-f6d6c0055188
Set id: d9492d51-ce02-48c6-af99-81b7d58319e4
Version: 2
Effective Time: 20170120
 
NeoStrata Company Inc