SKIN LIGHTENING COMPLEX- hydroquinone cream

SKIN LIGHTENING COMPLEX by

Drug Labeling and Warnings

SKIN LIGHTENING COMPLEX by is a Otc medication manufactured, distributed, or labeled by G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Hydroquinone (2.0%)

Purpose

skin lightener

Indications

• reduce dark blotches and spots
• even out skin tone and reduce skin discoloration

Warnings

For external use only

Avoid eye contact

Discontinue use if irritation occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

• Apply a thin coat to the affected area twice daily or as directed by your physician
• Utilize sunscreen daily

Inactive Ingredients

Aqua (Water), Glycolic Acid, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, Stearyl Alcohol, C12-C15 Alkyl Benzoate, Hydroxypropyl Starch Phosphate, Dimethicone, Sodium Hydroxide, Myristyl Alcohol, Glyceryl Stearate, Butyl Octyl Salicylate, Myristyl Glucoside, PEG 100 Stearate, Lactic Acid, Dehydroxanthan Gum, Sodium Metabisulfite, Camellia Oleifera Leaf Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Propylene Glycol, Phenoxy ethanol, Glycyrrhiza Glabra (Licorice) Root Extract, Arctostaphylos Uva Ursi Leaf Extract, Tocopheryl Acetate, BHT, Diazolidinyl Urea, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Disodium EDTA.

Other Information

• Read directions and warnings before use
• Store at room temperature 68°-77° F (20°-25° C)

SPL UNCLASSIFIED SECTION

Distributed by:
A&D Pharma LLC

PRINCIPAL DISPLAY PANEL - 30 g Tube Label

A&D
pharma

Skin
Lightening
Complex
with GLYCOLIC ACID

30 g

INGREDIENTS AND APPEARANCE

SKIN LIGHTENING COMPLEX 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65113-8401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (PHENOL - UNII:339NCG44TV)	HYDROQUINONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycolic Acid (UNII: 0WT12SX38S)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Glycerin (UNII: PDC6A3C0OX)
Cetyl Alcohol (UNII: 936JST6JCN)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)
Dimethicone (UNII: 92RU3N3Y1O)
Sodium Hydroxide (UNII: 55X04QC32I)
Myristyl Alcohol (UNII: V42034O9PU)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Polyoxyl 100 Stearate (UNII: YD01N1999R)
Lactic Acid (UNII: 33X04XA5AT)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Butylene Glycol (UNII: 3XUS85K0RA)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Propylene Glycol (UNII: 6DC9Q167V3)
Phenoxyethanol (UNII: HIE492ZZ3T)
Glycyrrhiza Glabra (UNII: 2788Z9758H)
Arctostaphylos Uva-Ursi Leaf (UNII: 3M5V3D1X36)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Ethylparaben (UNII: 14255EXE39)
Butylparaben (UNII: 3QPI1U3FV8)
Isobutylparaben (UNII: 0QQJ25X58G)
Edetate Disodium (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65113-8401-1	30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	12/09/2009

Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE