SLMD Skincare by Sandra Lee, M.D. - Dark Spot Fix

Manufacturer
SKIN PS BRANDS
Effective date
2020-02-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:30:47

Label at a glance#

ProductSLMD Skincare by Sandra Lee, M.D. - Dark Spot Fix
Active ingredientHydroquinone
Label structure11 sections

Dosage and administration

Adults: Apply a small amount as a thin layer on the affected area twice daily, 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 12 years of age: do not use unless directed by a doctor Sun exposure should be limited by using a sunscreen ...

Storage and handling

store in a cool, dry place.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2.0%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Use

INDICATIONS & USAGE SECTION

For the gradual fading of dark (brownish) discolorations in the skin such as freckles, age and liver spots, or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

Do not use

OTC - DO NOT USE SECTION

  • on children under 12 years of age unless directed by a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: Apply a small amount as a thin layer on the affected area twice daily, 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 12 years of age: do not use unless directed by a doctor
  • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring
  • Sensitivity Test for a New User: apply product sparingly to one or two small affected areas during first 3 days. If no discomfort occurs, follow directions above.

Other information

STORAGE AND HANDLING SECTION

  • store in a cool, dry place.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Butylene Glycol, Caprylic/Capric Triglyceride, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Salicylic Acid, Kojic Acid, Squalane, Niacinamide, Sodium Hyaluronate, Phenoxyethanol, Xanthan Gum, Sodium Metabisulfite, Ethylhexylglycerin.

Questions or comments?

OTC - QUESTIONS SECTION

Visit us at slmdskincare.com@slmdskincare

SPL UNCLASSIFIED SECTION

Distributed by Skin PS Brands
Culver City, CA 90232

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SLMD
SANDRA LEE MD

CREATED BY

DR.
PIMPLE
PoPPER

Dark Spot Fix

2% Hydroquinone
Skin Lightening Gel

1.0 fl. oz. / 30 mL

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton
PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73318-399473318-3994-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML · Source PDF

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
79ceff28-5bd8-4653-bfdc-1fc5facea802d1a6bed2-eb7f-4eba-a3ee-140a708434912022-04-18WarningsExact identifier
spl set id: d1a6bed2-eb7f-4eba-a3ee-140a70843491

Reported adverse events (FAERS/openFDA)#

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