CICATRICURE SKIN LIGHTENING- hydroquinone cream 
Genomma Lab USA

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.

----------

Cicatricure® Skin Lightening Cream

Drug Facts

Active ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Use

Lightens dark (brownish) spots, freckles and discolorations of the skin.

Warnings

For external use only

Do not use on children under 12 years of age unless directed by a doctor.

When using this product

  • you may experience mild skin irritation
  • avoid contact with eyes.

Stop use and consult a doctor if skin irritation becomes severe.

If pregnant or breast-feeding, ask a doctor before use.

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

Directions

  • Adults: Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
  • Children under 12 years of age: Do not use unless directed by a doctor.
  • Exposure to the sun should be limited by using a sunscreen agent, sun blocking agent or protective clothing to cover bleached skin when using and after treatment is completed in order to prevent darkening from reoccurring.

Other information

  • Keep tightly closed.
  • Store at room temperature.
  • retain carton for full product information.

Inactive ingredients

Water, Mineral Oil, Isopropyl Myristate, Propylene Glycol, Cetyl Alcohol, Polysorbate 60, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Cetearyl Alcohol, Fragrance, Sodium Metabisulfite, Tocopheryl Acetate, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Beta-Carotene.

Questions or comments?

Call toll free 1 877 99 GENOM (43666)

Distributed by
Genomma Lab USA Inc., Houston,
TX 77027

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

Cicatricure®

MEDICAL
LIGHTENING

SKIN LIGHTENING CREAM

3 TECHNOLOGIES COMBINED

3

  • Lightens dark spots
  • Unifies
    skin tone
  • Helps moisturize
    & nourish

HYDROQUINONE 2%

DERMATOLOGIST-RECOMMENDED
INGREDIENT

Net Wt. 1.7 OZ (48 g)

PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
CICATRICURE SKIN LIGHTENING 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-702
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Mineral oil (UNII: T5L8T28FGP)  
Isopropyl myristate (UNII: 0RE8K4LNJS)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Cetyl alcohol (UNII: 936JST6JCN)  
Polysorbate 60 (UNII: CAL22UVI4M)  
PEG-100 stearate (UNII: YD01N1999R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-702-011 in 1 CARTON09/26/201909/19/2022
148 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A09/26/201909/19/2022
Labeler - Genomma Lab USA (832323534)

Revised: 9/2022
 
Genomma Lab USA