NeoStrata ® HQ Skin Lightening Gel

Manufacturer: NeoStrata Company Inc
Effective date: 2018-05-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:58:53

Label at a glance#

ProductNeoStrata HQ Skin Lightening

Active ingredientHYDROQUINONE

Label structure9 sections

Indications and 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

Dosage and administration

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.

Storage and handling

Store at 15-30°C (59-86°F) Color may intensify with time, but does not decrease effectiveness.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2.0%

Purpose

OTC - PURPOSE SECTION

Skin bleaching agent

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

Some users may develop a mild skin irritation.

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Rash or skin irritation develops and becomes severe.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other Information

STORAGE AND HANDLING SECTION

Store at 15-30°C (59-86°F)

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeoStrata^®
10
PHA

HQ Skin Lightening Gel
Polyhydroxy Formulation

Contains Lactobionic Acid + Hydroquinone + Kojic Acid

Net wt. 1 oz / 30 g

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	1
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	1
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
GLUCONOLACTONE	INACTIVE INGREDIENT	WQ29KQ9POT	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	1
KOJIC ACID	INACTIVE INGREDIENT	6K23F1TT52	1
LACTOBIONIC ACID	INACTIVE INGREDIENT	65R938S4DV	1
OXALIC ACID	INACTIVE INGREDIENT	9E7R5L6H31	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM BISULFITE	INACTIVE INGREDIENT	TZX5469Z6I	1
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NeoStrata HQ Skin Lightening
HYDROQUINONE
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58414-8808	58414-8808-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROQUINONE	XV74C1N1AE	ACTIB
ALCOHOL	3K9958V90M	IACT
WATER	059QF0KO0R	IACT
ARGININE	94ZLA3W45F	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLUCONOLACTONE	WQ29KQ9POT	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
KOJIC ACID	6K23F1TT52	IACT
LACTOBIONIC ACID	65R938S4DV	IACT
OXALIC ACID	9E7R5L6H31	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM BISULFITE	TZX5469Z6I	IACT
SODIUM SULFITE	VTK01UQK3G	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 355 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOBIONIC ACID	LACTOBIONIC ACID	65R938S4DV	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 2 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	OIL / TOPICAL		2 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	TABLET, FILM COATED / ORAL		25 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BISULFITE	SODIUM BISULFITE	TZX5469Z6I	SOLUTION / IONTOPHORESIS	0.06 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	TABLET / ORAL	5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		414 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		81 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ARGININE	ARGININE	94ZLA3W45F	TABLET / ORAL		50 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / BUCCAL		9 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE, LIQUID FILLED / ORAL		360 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BISULFITE	SODIUM BISULFITE	TZX5469Z6I	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	INJECTION / INTRAVENOUS		96 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
GLUCONOLACTONE	GLUCONOLACTONE	WQ29KQ9POT	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM BISULFITE	SODIUM BISULFITE	TZX5469Z6I	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	SOLUTION/ DROPS / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	SUSPENSION / ORAL	1.15 mg/1ml		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAVENOUS		772 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, COATED / ORAL	7.93 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	ELIXIR / ORAL	27.5 mg/5ml		Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM BISULFITE	SODIUM BISULFITE	TZX5469Z6I	INJECTION / INTRAMUSCULAR		96 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM BISULFITE	SODIUM BISULFITE	TZX5469Z6I	INJECTION, SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii candidate 61 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
78771c04-1fd3-42f2-b44b-1f99e42a3793			3cb25504-d1bc-4bad-a712-72e13162a8da	2018-05-04	Warnings	Exact identifier spl id: 78771c04-1fd3-42f2-b44b-1f99e42a3793 spl set id: 3cb25504-d1bc-4bad-a712-72e13162a8da

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.