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Name:Neostrata Hq Skin Lightening
Manufacturer:Neostrata Company Inc
Category:Over-the-counter (OTC) Marketed Drugs


NeoStrata® HQ Skin Lightening Gel

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 Type HUMAN OTC DRUG Item Code (Source) NDC:58414-8006
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 0.02 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
WATER  
ARGININE  
BUTYLATED HYDROXYTOLUENE  
D&C RED NO. 33  
FD&C YELLOW NO. 5  
ANHYDROUS CITRIC ACID  
GLUCONOLACTONE  
GLYCYRRHIZA GLABRA  
KOJIC ACID  
LACTOBIONIC ACID  
OXALIC ACID  
POTASSIUM HYDROXIDE  
PROPYLENE GLYCOL  
SODIUM BISULFITE  
SODIUM SULFITE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58414-8006-1 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (58414-8006-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part358A 02/22/2011

Labeler - NeoStrata Company Inc (605754829)
Establishment
Name Address ID/FEI Operations
San-Mar Laboratories, Inc. 078718053 MANUFACTURE

Revised: 02/2011 NeoStrata Company Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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