TEATRICAL PRO-ACLARANT 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.

----------

Teatrical® Pro-Aclarant Skin Lightening Cream

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

Other information

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

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
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)

Revised: 4/2020
Document Id: 975473b0-1767-4756-9fab-bc36d38db0b5
Set id: c20869a0-1b14-4df5-aeab-ce9c85513141
Version: 1
Effective Time: 20200422
 
Genomma Lab USA