NeoStrata® HQ Skin Lightening Gel

NeoStrata HQ Skin Lightening by

Drug Labeling and Warnings

NeoStrata HQ Skin Lightening by is a Otc medication manufactured, distributed, or labeled by NeoStrata Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

NEOSTRATA HQ SKIN LIGHTENING 
hydroquinone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-8808
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58414-8808-1	1 in 1 CARTON	02/22/2011	11/30/2019
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part358A	02/22/2011	11/30/2019

Labeler - NeoStrata Company Inc (605754829)

Revised: 5/2018

Document Id: 78771c04-1fd3-42f2-b44b-1f99e42a3793

34390-5

Set id: 3cb25504-d1bc-4bad-a712-72e13162a8da

Version: 2

Effective Time: 20180504

 

NeoStrata Company Inc