Meaningful Beauty Dark Spot Correcting Treatment: Package Insert and Label Information

MEANINGFUL BEAUTY DARK SPOT CORRECTING TREATMENT- hydroquinone lotion
Guthy-Renker LLC

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.

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

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

PRINCIPAL DISPLAY PANEL -- 30mL Tube Box
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
OCTYLDODECANOL
CYCLOMETHICONE 5
HEXYLENE GLYCOL
POLYQUATERNIUM-37 (10000 MPA.S)
GLYCOLIC ACID
CYCLOMETHICONE 6
CETOSTEARYL ALCOHOL
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE
ASCORBYL PALMITATE
VITAMIN A PALMITATE
PROPYLENE GLYCOL
GLYCERYL DILAURATE
PPG-1 TRIDECETH-6
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
PEG-40 STEARATE
SODIUM SULFITE
SODIUM METABISULFITE
SODIUM HYDROXIDE
EDETATE DISODIUM
DIAZOLIDINYL UREA
METHYLPARABEN
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70605-007-29 1 TUBE in 1 BOX contains a TUBE
1 2 mL in 1 TUBE This package is contained within the BOX (70605-007-29)
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)

Revised: 10/2016 Guthy-Renker LLC

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