SKIN LIGHTENING COMPLEX

Dosage form: cream
Ingredients: HYDROQUINONE 2g in 100g
Labeler: G.S. COSMECEUTICAL USA, INC.
NDC Code: 65113-8401

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
  • 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)

Distributed by:
A&D Pharma LLC

PRINCIPAL DISPLAY PANEL - 30 g Tube Label

A&D
pharma

Skin
Lightening
Complex
with GLYCOLIC ACID

30 g

SKIN LIGHTENING COMPLEX 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65113-8401
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (PHENOL) HYDROQUINONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycolic Acid 
Medium-Chain Triglycerides 
Glycerin 
Cetyl Alcohol 
Stearyl Alcohol 
C12-15 Alkyl Benzoate 
Dimethicone 
Sodium Hydroxide 
Myristyl Alcohol 
Glyceryl Monostearate 
Polyoxyl 100 Stearate 
Lactic Acid 
Sodium Metabisulfite 
Butylene Glycol 
Green Tea Leaf 
Propylene Glycol 
Phenoxyethanol 
Glycyrrhiza Glabra 
Arctostaphylos Uva-Ursi Leaf 
Alpha-Tocopherol Acetate 
Butylated Hydroxytoluene 
Diazolidinyl Urea 
Methylparaben 
Propylparaben 
Ethylparaben 
Butylparaben 
Isobutylparaben 
Edetate Disodium 
Packaging
#Item CodePackage Description
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/FEIOperations
G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE

Revised: 09/2010
 
G.S. COSMECEUTICAL USA, INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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