LIGHTENING HQ SPOT- hydroquinone cream 
Gate Therapeutics

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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Lightening + HQ Spot Treatment

Active ingredient           Purpose

Hydroquinone 2%         Skin Lightener

Uses: ​For the gradual fading of drark (brownish) areas in the skin such as freckles, age and liver spots.

Keep out of reach of children. If product is swallowed, get medical help or call the Poison Control Center right away.

When using this product avoid contat with eyes

Warnings:

  • For external Use only. If pregnant or breast feeding: ask a healthcare professional before use.
  • Do not use: on children under 12 years of age unless directed by a doctor.
  • When using this product Avoid contact with eyes. Some users of this product may experience mild irritation. If skin irritation becomes severe  stop use and consult a doctor

Directions

  • Adults: apply a small amount (1-2) pumps as a thin layer on the affected area twice a day or as directed by a doctor. If no improvement is seen after three months of treatment, use of this product should be discontinued. Lightening effects of this product may not be noticeable 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 or protective clothing to cover bleached skin when using and after using this product to prevent redarkening from occuring.

Inactive ingredients:

Water, Propylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Isopropyl Palmitate, Butylene Glycol, Glycerin, PEG-100 Stearate, Cetearyl Alcohol, Azelaic Acid, Cetyl Phosphate, Triethanolamine, Arbutin, Frangrance, Kojic Acid, Phenylehtyl Resorcinol, Rumex Occidentalis Extract, Lactic Acid, Sodium Ascorbyl Phosphate, Dimethicone, Aloe Barbadensis Leaf Extract, Arctostaphylos Uva-Ursi Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Morus Alba Fruit Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Zea Mays (Corn) Oil, Ceteth-10 Phosphate, Dicetyl Phosphate, Bisabolol, Ascorbic Acid, Pentylene Glycol, Sebacic Acid, Suberic Acid, Xanthan Gum, Tetrasodium EDTA, BHT, Undecanedioc Acid, Sodium Metabisulfate, Dehydroacetic Acid, Benzyl Alcohol.

Lightening Cream + HQ  Spot Treatment

1.7Fl Oz/ 50mL

Pump

LIGHTENING HQ SPOT 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72274-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
AZELAIC ACID (UNII: F2VW3D43YT)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
TROLAMINE (UNII: 9O3K93S3TK)  
ARBUTIN (UNII: C5INA23HXF)  
KOJIC ACID (UNII: 6K23F1TT52)  
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
LACTIC ACID (UNII: 33X04XA5AT)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
LICORICE (UNII: 61ZBX54883)  
WHITE MULBERRY (UNII: MN25R0HH5A)  
CORN OIL (UNII: 8470G57WFM)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
LEVOMENOL (UNII: 24WE03BX2T)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SEBACIC ACID (UNII: 97AN39ICTC)  
SUBERIC ACID (UNII: 6U7Y4M9C1H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE SODIUM (UNII: MP1J8420LU)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
UNDECANEDIOIC ACID (UNII: 7059GFK8NV)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72274-001-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/24/201811/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A04/23/201811/30/2021
Labeler - Gate Therapeutics (081159085)

Revised: 11/2021
 
Gate Therapeutics