LIGHTENING HQ SPOT- hydroquinone cream

Lightening HQ Spot by

Drug Labeling and Warnings

Lightening HQ Spot by is a Otc medication manufactured, distributed, or labeled by Gate Therapeutics, VEGE-KURL, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient           Purpose

Hydroquinone 2%         Skin Lightener

PURPOSE

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

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

INDICATIONS & USAGE

When using this product avoid contat with eyes

WARNINGS

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Lightening Cream + HQ  Spot Treatment

1.7Fl Oz/ 50mL

INGREDIENTS AND APPEARANCE

LIGHTENING HQ SPOT 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72274-001
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72274-001-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/24/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	04/23/2018

Labeler - Gate Therapeutics (081159085)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC		021072509	manufacture(72274-001)