BRIGHT MALIKA AND KHADIJA BRIGHTENING SPOT TREATMENT- hydroquinone cream

Bright Malika and Khadija Brightening Spot Treatment by

Drug Labeling and Warnings

Bright Malika and Khadija Brightening Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Pulsaderm, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

ACTIVE INGREDIENT:

Hydroquinone 2.00%

Skin Lightener

USES:

Lightens dark spots in the skin such as freckles, age spots and liver spots.

WARNINGS:

*For external use only.
*Avoid contact with eyes or eyelids.
*Some users of this product may experience mild skin irritation. Consult physician if skin irritation becomes severe.

Do not use on

children under 12, unless directed by physician.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, contact physician or poison control center immediately.

SPL UNCLASSIFIED SECTION

Store at room temperature.

DIRECTIONS:

Adults: Apply a thin layer on the affected areas twice daily, or as directed by physician.

• If no improvement is seen after three months of treatment, discontinue use of this product and consults physician.
• Lightening effect of this product may be less noticeable on very dark skin.
• Children under 12-years of age: Do not use this product unless directed by physician 
• Sun exposure should be limited by using sunscreen agent, sun blocking agent, or protective clothing to cover bleached skin when using, and after using this product, in order to prevent darkening from reoccurring.

OTHER INGREDIENTS:

Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Bis-Vinyl Dimethicone/Dimethicone Copolymer, Butylene Glycol, C12-15 Alkyls Benzoate, Caprylic/Capric Triglyceride, 
Cyclopentasiloxane, Diazolidinyl Urea, Glucosamine HCI, Glycerin, Glycolic Acid, Glycyrrhiza Glabra (Licorice) Extract,
Hydroxyethylcellulose, lsohexadecane, Kojic Acid, Methyl Paraben, Morus Alba (Mulberry) Extract, Polysorbate 80, Propyl Paraben,
Propylene Glycol, Sodium Acryloyldimethyl Taurate Copolymer, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Metabisulfite,
Sodium PCA, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Urea, Vitis Vinifera (Grape) Seed Extract, Yeast Extract.

Package Labeling:

INGREDIENTS AND APPEARANCE

BRIGHT MALIKA AND KHADIJA BRIGHTENING SPOT TREATMENT 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71177-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOLIC ACID (UNII: 0WT12SX38S)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ISOHEXADECANE (UNII: 918X1OUF1E)
KOJIC ACID (UNII: 6K23F1TT52)
METHYLPARABEN (UNII: A2I8C7HI9T)
WHITE MULBERRY (UNII: MN25R0HH5A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
UREA (UNII: 8W8T17847W)
GRAPE (UNII: 6X543N684K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71177-008-15	1 in 1 BOX	03/01/2019
1		15 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	03/01/2019

Labeler - Pulsaderm, LLC (080429881)