SKIN LIGHTENING COMPLEX- hydroquinone cream 
G.S. COSMECEUTICAL USA, INC.

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.

----------

A&D pharma
Skin
Lightening
Complex
with GLYCOLIC ACID

Drug Facts

Active ingredients

Hydroquinone (2.0%)

Purpose

skin lightener

Indications

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

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

Distributed by:
A&D Pharma LLC

PRINCIPAL DISPLAY PANEL - 30 g Tube Label

A&D
pharma

Skin
Lightening
Complex
with GLYCOLIC ACID

30 g

Principal Display Panel - 30 g Tube Label
SKIN LIGHTENING COMPLEX 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65113-8401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (PHENOL - UNII:339NCG44TV) HYDROQUINONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65113-8401-130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A12/09/2009
Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE

Revised: 9/2010
Document Id: 747d192d-0a31-44b3-8dff-71cb2aa196ea
Set id: 8c0ab847-bca6-4e0a-acfe-07a8323aa41c
Version: 1
Effective Time: 20100902
 
G.S. COSMECEUTICAL USA, INC.