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Pigment Control Program - Hydroquinone

Generic name: hydroquinone
Dosage form: kit
Drug class: Topical depigmenting agents

Medically reviewed by Drugs.com. Last updated on March 1, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

PIGMENT CONTROL CREME

(Hydroquinone USP, 4%)

RX ONLY

FOR EXTERNAL USE ONLY:

NOT FOR OPHTHALMIC USE

Pigment Control Program - Hydroquinone Description

Hydroquinone is 1,4-benzendiol, with a chemical formula of C6H6O2 and a molecular weight of 110.11.

The structural formula is:

Each gram of Pigment Control Creme (Hydroquinone USP, 4%) contains Hydroquinone USP 40 mg/gm in a base of Purified Water, Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Glycerin, Glycolic Acid, Phenoxyethanol, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

Pigment Control Program - Hydroquinone - Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause re-pigmentation of bleached areas, which may be prevented by the use of the sunscreen agents.

Indications and Usage for Pigment Control Program - Hydroquinone

Pigment Control Creme is indicated in the gradual bleaching of hyperpigmentation, skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Contraindications

Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical Hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Warnings

Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation from occurring.

Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician.

Avoid contact with eyes and mucous membranes. Keep out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

Precautions

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

Drug Interactions

Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

Pregnancy Category C

Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

Pediatric Use

Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

Adverse Reactions

The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

Overdosage

There have been no system reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

DRUG DOSAGE AND ADMINISTRATION

A thin layer of Pigment Control Creme (Hydroquinone USP, 4%) should be applied to the affected area twice daily or as directed by a physician. If no improvement is seen after 8-12 weeks of treatment, use of this product should be discontinued. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

How is Pigment Control Program - Hydroquinone Supplied

Pigment Control Creme (Hydroquinone USP, 4%) is available as follows:

2.7 Fl. Oz. (80 mL) Bottle / NDC 42851-037-80

1.0 fl oz/30 ml Bottle / NDC 42851-037-30

STORAGE

Store at controlled room temperature: 15°-30°C (59°-86°F)

PIGMENT CONTROL + BLENDING CREME
(Hydroquinone USP, 4%)

RX ONLY
FOR EXTERNAL USE ONLY:
NOT FOR OPHTHALMIC USE

Pigment Control Program - Hydroquinone Description

Hydroquinone is 1,4-benzendiol, with a chemical formula of C6H6O2 and a molecular weight of 110.11.

The structural formula is:

Each gram of Pigment Control + Blending Creme contains Hydroquinone USP 40mg/gm in a base of Ascorbic Acid, Ascorbyl Palmitate, Beta-Glucan, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dioscorea Villosa (Wild Yam) Root Extract, Disodium EDTA, Ethylhexyl Palmitate, Glycerin, Glycolic Acid, Palmitic Acid, Phenoxyethanol, Phenyl Trimethicone, Purified Water, Quillaja Saponaria Bark Extract, Smilax Aristolochiifolia Root Extract, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Sulfite, Stearyl Alcohol, Tocopheryl Acetate, Yucca Schidigera Root Extract.

Pigment Control Program - Hydroquinone - Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause re-pigmentation of bleached areas, which may be prevented by the use of the sunscreen agents.

Indications and Usage for Pigment Control Program - Hydroquinone

For the gradual bleaching of hyperpigmented skin conditions such as cholasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Contraindications

Prior history of sensitivity or allergic reaction to hydroquinone or to any other ingredient in this product. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Warnings

Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation from occurring.

Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician.

Avoid contact with eyes and mucous membranes. Keep out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

Precautions

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin; check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.

Drug Interactions

Patients are cautioned on concomitant use of medications that are known to be photosensitizing.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.

Pregnancy Category C

Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether topical hydroquinone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Topical hydroquinone should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when topical hydroquinone is administered to a nursing woman.

Pediatric Use

Safety and effectiveness for pediatric patients below the age of 12 years have not been established.

Adverse Reactions

The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

Overdosage

There have been no system reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

DRUG DOSAGE AND ADMINISTRATION

A thin application of Pigment Control + Blending Creme should be applied to the affected area twice daily or as directed by a physician. Consult product label for instructions on whether to rub in or not. There is no recommendation for children under 12 years of age except under the advice and supervision of a physician.

How is Pigment Control Program - Hydroquinone Supplied

Pigment Control + Blending Creme (Hydroquinone USP, 4%) is available as follows:

2.7 Fl. Oz. (80 mL) Bottle / NDC 42851-036-80

1.0 Fl. Oz (30 mL) Bottle / NDC 42851-036-30

STORAGE

Store at controlled room temperature: 15°-30°C (59°-86°F)

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

PIGMENT CONTROL PROGRAM

+ HYDROQUINONE

NDC 42851-184-60

GENTLE CLEANSER 60 mL / 2 Fl. Oz.

EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.

COMPLEXION RENEWAL PADS 30 Pads

PIGMENT CONTROL CRÈME 30 mL / 1.0 Fl. Oz.

DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.

PIGMENT CONTROL + BLENDING CREME 30 mL / 1 Fl. Oz.

Established Pharmacological Class
Substance Pharmacological Class
ZO Skin Health Gentle Cleanser Cleansing (cold creams, cleansing lotions, liquids, and pads)
ZO Skin Health Exfoliating Polish Lotions, Oils, Powders, and Creams
ZO Skin Health Complexion Renewal Pads Cleansing (cold creams, cleansing lotions, liquids, and pads)
ZO Skin Health Daily Power Defense Other Skin Care Preparations
ZO SKIN HEALTH PIGMENT CONTROL PROGRAM PLUS HYDROQUINONE
hydroquinone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42851-184
Packaging
# Item Code Package Description
1 NDC:42851-184-60 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 60 mL
Part 2 1 JAR 16.2 g
Part 3 30 JAR 30
Part 4 1 BOTTLE, PLASTIC 30 mL
Part 5 1 BOTTLE, PLASTIC 30 mL
Part 6 1 BOTTLE, PUMP 30 mL
Part 1 of 6
ZO SKIN HEALTH GENTLE CLEANSER
gel
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
SODIUM LAURETH-3 SULFATE
COCAMIDOPROPYL BETAINE
SODIUM LAUROYL OAT AMINO ACIDS
GLYCERIN
GREEN TEA LEAF
LIMONENE, (+/-)-
LINALOOL, (+/-)-
SODIUM CHLORIDE
BUTYLENE GLYCOL
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
FD&C BLUE NO. 1
D&C RED NO. 33
Packaging
# Item Code Package Description
1 60 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 03/09/2021
Part 2 of 6
ZO SKIN HEALTH EXFOLIATING POLISH
suspension
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
POLYETHYLENE GLYCOL 400
SODIUM BICARBONATE
MAGNESIUM OXIDE
DIETHYLENE GLYCOL MONOETHYL ETHER
GLYCERIN
BUTYLENE GLYCOL
OLETH-20
TRIHYDROXYSTEARIN
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
MINERAL OIL
WATER
.ALPHA.-TOCOPHEROL ACETATE, DL-
TEA TREE OIL
SOY STEROL
LIMONENE, (+/-)-
LINALOOL, (+/-)-
ASCORBYL PALMITATE
VITAMIN A PALMITATE
STEARYL GLYCYRRHETINATE
TETRAHEXYLDECYL ASCORBATE
MEDIUM-CHAIN TRIGLYCERIDES
LINOLEIC ACID
LECITHIN, SOYBEAN
PHENOXYETHANOL
D&C GREEN NO. 6
Packaging
# Item Code Package Description
1 16.2 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 03/09/2021
Part 3 of 6
ZO SKIN HEALTH COMPLEXION RENEWAL PADS
patch
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
ALCOHOL
SALICYLIC ACID
SODIUM HYDROXIDE
GLYCOLIC ACID
SODIUM CARBONATE
EDETATE DISODIUM ANHYDROUS
DENATONIUM BENZOATE
PHENOXYETHANOL
.BETA.-CITRONELLOL, (R)-
.ALPHA.-HEXYLCINNAMALDEHYDE
LINALOOL, (+/-)-
BARLEY
BUTYLENE GLYCOL
SODIUM CHLORIDE
TERT-BUTYL ALCOHOL
PTEROCARPUS SOYAUXII WOOD
GREEN TEA LEAF
LIMONENE, (+)-
WATER
PROPYLENE GLYCOL
UREA
PHELLODENDRON AMURENSE BARK
CRITHMUM MARITIMUM
PLANTAGO LANCEOLATA LEAF
Packaging
# Item Code Package Description
1 1 PATCH in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 03/09/2021
Part 4 of 6
ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE
hydroquinone emulsion
Product Information
Item Code (Source) NDC:42851-037
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ASCORBIC ACID
ASCORBYL PALMITATE
CAPRYLYL GLYCOL
CETYL ALCOHOL
CHLORPHENESIN
DIOSCOREA VILLOSA TUBER
EDETATE DISODIUM ANHYDROUS
GLYCERIN
GLYCOLIC ACID
PHENOXYETHANOL
QUILLAJA SAPONARIA BARK
SMILAX ARISTOLOCHIIFOLIA ROOT
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
SODIUM METABISULFITE
SODIUM SULFITE
STEARYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
YUCCA SCHIDIGERA ROOT
Packaging
# Item Code Package Description
1 30 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/09/2021
Part 5 of 6
ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE
hydroquinone emulsion
Product Information
Item Code (Source) NDC:42851-036
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 0.04 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
ASCORBYL PALMITATE
CAPRYLYL GLYCOL
CETYL ALCOHOL
CHLORPHENESIN
DIOSCOREA VILLOSA TUBER
EDETATE DISODIUM ANHYDROUS
ETHYLHEXYL PALMITATE
GLYCERIN
GLYCOLIC ACID
PALMITIC ACID
PHENOXYETHANOL
PHENYL TRIMETHICONE
QUILLAJA SAPONARIA BARK
SMILAX ARISTOLOCHIIFOLIA ROOT
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
SODIUM METABISULFITE
SODIUM SULFITE
STEARYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE, DL-
WATER
YUCCA SCHIDIGERA ROOT
Packaging
# Item Code Package Description
1 30 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/09/2021
Part 6 of 6
ZO SKIN HEALTH DAILY POWER DEFENSE
lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
PENTYLENE GLYCOL
POWDERED CELLULOSE
RETINOL
LIMONENE, (+)-
CETOSTEARYL ALCOHOL
C12-20 ALKYL GLUCOSIDE
LACTOSE, UNSPECIFIED FORM (ANHYDROUS LACTOSE)
HYPROMELLOSE, UNSPECIFIED
PALMITOYL TETRAPEPTIDE-7
PALMITOYL TRIPEPTIDE-1
BUTYLENE GLYCOL
CAPRYLYL GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
CYCLOMETHICONE 5
GLYCERIN
CETEARYL ISONONANOATE
CYCLOMETHICONE 6
STEARETH-20
SODIUM HYDROXIDE
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
EXT. D&C VIOLET NO. 2
VITAMIN A PALMITATE
HEXYLENE GLYCOL
ARABIDOPSIS THALIANA
EDETATE DISODIUM ANHYDROUS
ULTRAMARINE BLUE
C14-22 ALCOHOLS
CETEARYL GLUCOSIDE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
WATER
1,2-HEXANEDIOL
Packaging
# Item Code Package Description
1 30 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 03/09/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/09/2021
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
Name Address ID/FEI Operations
Goodier Cosmetics LLC 007317209 manufacture(42851-184)
Establishment
Name Address ID/FEI Operations
LIFETECH RESOURCES LLC 622559110 manufacture(42851-184)
Establishment
Name Address ID/FEI Operations
AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care 872684803 analysis(42851-184), label(42851-184), manufacture(42851-184), pack(42851-184)
ZO Skin Health, Inc.