PLEXADERM Dark Spot Fade Gel

PLEXADERM Dark Spot Fade Gel by

Drug Labeling and Warnings

PLEXADERM Dark Spot Fade Gel by is a Otc medication manufactured, distributed, or labeled by True Earth Health Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PLEXADERM DARK SPOT FADE GEL- hydroquinone gel 
True Earth Health Products

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.

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PLEXADERM Dark Spot Fade Gel

Drug Facts

Active Ingredients

Hydroquinone 2%

Purpose

Skin Lightener

Uses

For the gradual fading of 

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

Warnings

For external use only.

Do not use

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

When using this product

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

Stop use and ask a doctor

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

If pregnant or nursing

Ask a doctor before use.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • 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

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

Protect this product from excessive heat and direct sun.

Package Labeling:

Label

PLEXADERM DARK SPOT FADE GEL 
hydroquinone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81097-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AZELAIC ACID (UNII: F2VW3D43YT)  
LEVOMENOL (UNII: 24WE03BX2T)  
AVOBENZONE (UNII: G63QQF2NOX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
KOJIC ACID (UNII: 6K23F1TT52)  
LACTIC ACID (UNII: 33X04XA5AT)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
CORN (UNII: 0N8672707O)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81097-107-151 in 1 BOX11/09/202010/31/2023
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A11/09/202010/31/2023
Labeler - True Earth Health Products (035401955)

Revised: 4/2022
Document Id: dcf39e60-9d82-4346-e053-2a95a90a6e99
Set id: 8a348c4b-a861-414a-a24d-e110524874ce
Version: 3
Effective Time: 20220418