CLARITE 4

Main information

  • Trade name:
  • CLARITE 4- hydroquinone cream
  • Composition:
  • HYDROQUINONE 4 g in 100 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLARITE 4- hydroquinone cream
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 67226-2040-6
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

CLARITE 4- hydroquinone cream

Vivier Pharma, 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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Clarite 4

Active Ingredient

Hydroquinone USP (4%)

Indication

Skin Bleaching and Correcting

Indication

To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or

hyperpigmentation that can occur as a result of pregnancy or the use of oral contraceptives.

Precautions

For external use only. Use only on the advice of a physician. A mild transient stinging may occur for

people with sensitive skin. Do not use on broken or irritated skin. Discontinue use if irritation or rash

occurs. Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with

water. Do not use on children under 12 years of age. Keep out of reach of children. Avoid usage

around the eyes and lips.

Precautions

Keep out of reach of children.

Directions

Use fingertips to apply a thin layer to affected areas. Use both morning and night or as directed by a

physician. Gradual lightening of the discolored area can be expected in most cases. Close cap securely

after each use. Store at room temperature (15-30°C / 59-86°F).

Non-Medicinal Ingredients

Butylated Hydroxy Toluene, Butylparaben, Cetearyl Alcohol, Cetyl Alcohol, Disodium EDTA,

Ethoxydiglycol, Fragrance/Parfum (Carubba C6929), Glycerin, Lactic Acid, L-Ascorbic Acid USP,

Methylparaben, Phenyl Trimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Sodium

Cetearyl Sulfate, Sodium Lauryl Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Water/Eau.

Principal Display Panel

CLARITE 4

hydroquinone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7226 -20 40

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO Q UINO NE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)

HYDROQUINONE

4 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

DIETHYLENE GLYCO L MO NO ETHYL ETHER (UNII: A1A1I8 X0 2B)

GLYCERIN (UNII: PDC6 A3C0 OX)

LACTIC ACID (UNII: 33X0 4XA5AT)

Vivier Pharma, Inc.

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PHENYL TRIMETHICO NE (UNII: DR0 K5NOJ4R)

PPG-2 MYRISTYL ETHER PRO PIO NATE (UNII: 8 8 R9 7D8 U8 A)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SO DIUM CETO STEARYL SULFATE (UNII: 7ZBS0 6 BH4B)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM METABISULFITE (UNII: 4VON5FNS3C)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7226 -20 40 -6

1 in 1 BOX

1

6 0 mL in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt358 A

0 5/30 /20 14

Labeler -

Vivier Pharma, Inc. (250996550)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vivier Pharma, Inc.

250 9 9 6 550

ma nufa c ture (6 7226 -20 40 )

Revised: 11/2013