MEANINGFUL BEAUTY DARK SPOT CORRECTING TREATMENT- hydroquinone lotion

Meaningful Beauty Dark Spot Correcting Treatment by

Drug Labeling and Warnings

Meaningful Beauty Dark Spot Correcting Treatment by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Use

lightens discoloration spots and blotches in the skin such as age and liver spots

Warnings

For external use only

• avoid contact with the eyes, lips, and mouth.

• do not use on children under 12 years of age unless directed by a doctor.

Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

If pregnant or breastfeeding, ask a health professional before use.

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

Directions

• 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 noticed 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 recurring.

Inactive ingredients

Water, octyldodecanol, cyclopentasiloxane, hexylene glycol, polyquaternium-37, glycolic acid, cyclohexasiloxane, cetearyl alcohol, propylene glycol dicaprylate/dicaprate, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, propylene glycol, glyceryl dilaurate, PPG-1 trideceth-6, glyceryl stearate, PEG-100 stearate, PEG-40 stearate, sodium sulfite, sodium metabisulfite, sodium hydroxide, disodium EDTA, diazolidinyl urea, methylparaben, propylparaben, fragrance

Questions or comments?

Within US 1-800-490-4134

SPL UNCLASSIFIED SECTION

Distributed by:
Meaningful Beauty®
Santa Monica, CA 90405

PRINCIPAL DISPLAY PANEL - 30mL Tube Box

Meaningful Beauty®
Cindy Crawford

Dark Spot
Correcting
Treatment

Contains hydroquinone
to help visibly reduce the
appearance of dark
pigmented age spots

Developed to help lighten
or fade dark age spots or
brown discoloration

Skin Lightener
1 FL OZ/30mL

INGREDIENTS AND APPEARANCE

MEANINGFUL BEAUTY DARK SPOT CORRECTING TREATMENT 
hydroquinone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTYLDODECANOL (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
GLYCOLIC ACID (UNII: 0WT12SX38S)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PEG-40 STEARATE (UNII: ECU18C66Q7)
SODIUM SULFITE (UNII: VTK01UQK3G)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-007-29	1 in 1 BOX	04/30/2016
1		2 mL in 1 TUBE; 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	04/30/2016

Labeler - Guthy-Renker LLC (948861877)