NEOSTRATA HQ SKIN LIGHTENING- 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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NeoStrata®
HQ Skin Lightening Gel

Drug Facts

Active Ingredient

Hydroquinone 2.0%

Purpose

Skin bleaching 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.

Other Information

Store at 15-30°C (59-86°F)

Color may intensify with time, but does not decrease effectiveness.

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.

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

NeoStrata®
10
PHA

HQ Skin Lightening Gel
Polyhydroxy Formulation

Contains Lactobionic Acid + Hydroquinone + Kojic Acid

Net wt. 1 oz / 30 g

Principal Display Panel - 30 g Carton
NEOSTRATA HQ SKIN LIGHTENING 
hydroquinone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-8808
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:58414-8808-11 in 1 CARTON02/22/201111/30/2019
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 FINALpart358A02/22/201111/30/2019
Labeler - NeoStrata Company Inc (605754829)

Revised: 5/2018
Document Id: 78771c04-1fd3-42f2-b44b-1f99e42a3793
Set id: 3cb25504-d1bc-4bad-a712-72e13162a8da
Version: 2
Effective Time: 20180504
 
NeoStrata Company Inc