SLMD SKINCARE BY SANDRA LEE, M.D. - DARK SPOT FIX- hydroquinone cream

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

Drug Labeling and Warnings

SLMD Skincare by Sandra Lee, M.D. - Dark Spot Fix by is a Otc medication manufactured, distributed, or labeled by SKIN PS BRANDS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Hydroquinone 2.0%

Purpose

Skin Lightener

Use

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

For external use only.

When using this product

• 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

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

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

Directions

• 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

• store in a cool, dry place.

Inactive Ingredients

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?

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

SLMD
SANDRA LEE MD

CREATED BY

DR.
PIMPLE
PoPPER

Dark Spot Fix

2% Hydroquinone
Skin Lightening Gel

1.0 fl. oz. / 30 mL

INGREDIENTS AND APPEARANCE

SLMD SKINCARE BY SANDRA LEE, M.D. - DARK SPOT FIX 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73318-3994
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)	Hydroquinone	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SALICYLIC ACID (UNII: O414PZ4LPZ)
KOJIC ACID (UNII: 6K23F1TT52)
SQUALANE (UNII: GW89575KF9)
NIACINAMIDE (UNII: 25X51I8RD4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73318-3994-1	1 in 1 CARTON	05/15/2020
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part358A	05/15/2020

Labeler - SKIN PS BRANDS (081085221)