PLEXADERM Dark Spot Fade Gel

Manufacturer
True Earth Health Products
Effective date
2022-04-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:03:23

Label at a glance#

ProductPLEXADERM Dark Spot Fade Gel
Active ingredientHYDROQUINONE
Label structure7 sections

Indications and uses

For the gradual fading of  dark spots age spots freckles brownish skin discolorations

Dosage and administration

Adults: apply a thin layer on the affected area once daily in the evening, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin. Children under 16 years of age: do not use unless directed by a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Uses

INDICATIONS & USAGE SECTION

For the gradual fading of 

  • dark spots
  • age spots
  • freckles
  • brownish skin discolorations

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • On children under 16 years age unless directed by a doctor.
  • On damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • Avoid direct contact with eyes.
  • Avoid unnecessary sun exposure and always use sunscreen.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If skin irritation becomes severe. some users of this product may experience a mild skin irritation.

If pregnant or nursing

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a doctor before 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: apply a thin layer on the affected area once daily in the evening, or use as directed by a doctor.
  • If no improvement is seen after 3 months of treatment, use of this product should be discontinued.
  • Lightening effect of this product may not be noticeable when used on very dark skin.
  • Children under 16 years of age: do not use unless directed by a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Azelaic Acid, Bisabolol, Butyl Methoxydibenzoylmethane, Caprylic/Capric Triglyceride, Ethylhexylglycerin, Glycolic Acid, Hydroxyethylcellulose, Kojic Acid, Lactic Acid, PEG-8 Dimethicone, Pentylene Glycol, Phenoxyethanol, Phenylethyl Resorcinol, Sodium Hydroxide, Sodium Metabisulfite, Zemea (Corn) Propanediol.

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81097-10781097-107-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dcf39e60-9d82-4346-e053-2a95a90a6e998a348c4b-a861-414a-a24d-e110524874ce2022-04-18WarningsExact identifier
spl id: dcf39e60-9d82-4346-e053-2a95a90a6e99
spl set id: 8a348c4b-a861-414a-a24d-e110524874ce

Reported adverse events (FAERS/openFDA)#

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