Label: TEATRICAL PRO-ACLARANT SKIN LIGHTENING- hydroquinone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated April 22, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydroquinone 2%

  • Purpose

    Skin Lightener

  • Use

    Lightens dark (brownish) spots, blotches, 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.
  • Inactive ingredients

    water, mineral oil, glyceryl stearate, cetyl alcohol, isopropyl myristate, PEG-100 stearate, propylene glycol, cetearyl alcohol, polysorbate 60, sodium metabisulfite, stearic acid, tocopheryl acetate, beta-carotene, diazolidinyl urea, iodopropynyl butylcarbamate, fragance

  • Questions or comments?

    Call toll free 1-877-994-3666

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

    teatrical®

    PRO-ACLARANT
    SKIN LIGHTENING

    NIGHT
    CREAM

    HYDROQUINONE 2%

    Lightens dark spots

    NET WT 1.7 OZ (48 g)

    PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TEATRICAL PRO-ACLARANT SKIN LIGHTENING 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-072
    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:50066-072-011 in 1 CARTON04/22/2020
    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 FINALpart358A04/22/2020
    Labeler - Genomma Lab USA (832323534)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!