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SYMBA Skin Lightening by Craig Doura LLC

Medically reviewed on December 28, 2017

Dosage form: cream
Ingredients: HYDROQUINONE 19mg in 1g
Labeler: Craig Doura LLC
NDC Code: 71607-300

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.

SYMBA® Skin Lightening

Drug Facts

Active Ingredients

Hydroquinone 1.9%

Purpose

Skin Lightening Agent

Uses

Gradually lightens uneven and dark discoloration. Fades freckles, age, and liver spots. Moisturizes the skin. Leaves skin perfumed, soft, and smooth.

For external use only

Warnings

Do not use
  • on irritated or broken skin
  • on children under 12 years old
  • to prevent sunburn
  • in combination with products containing Resorcinol, Phenol, or Salicylic Acid

When using this product
  • mild irritation or temporary skin darkening may occur
  • avoid contact with eyes
  • avoid unnecessary sun exposure

Stop use and consult a doctor if
  • darkening persists
  • irritation becomes severe

If pregnant or breast feeding, consult a doctor before use.

KEEP OUT OF REACH OF CHILDREN. If swallowed, call poison control or get medical attention immediately.

Directions
  • for sensitive skin, test overnight on a small section of skin inside the elbow before use
  • apply a thin layer to skin on affected areas
  • use sunscreen to prevent darkening from recurring
  • use twice daily for at least 6 weeks or as directed by doctor

Inactive Ingredients

Water (Aqua), Glyceryl Monostearate, Propylene Glycol, Carrot Seed Oil (Carica Carrot Fruit Extract), Mineral Oil (Paraffinum Liquidum), Cetyl Palmitate, Isopropyl Myristate, Dimethicone, Sodium Lauryl Sulphate, Allantoin, Fragrance (Parfum), Sodium Metabisulfite, Ascorbic Acid (Vitamin C), Propylparaben, Edetate Disodium, FD&C Red No.40.

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

SYMBA®
SKIN LIGHTENING CREAM

CARROT

With CARROT Fruit Extract, Vitamin A, and Vitamin E

NDC 71607-300-01

SYMBA SKIN LIGHTENING 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71607-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE19 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glyceryl Monostearate 
Propylene Glycol 
CARROT SEED OIL 
Mineral Oil 
Cetyl Palmitate 
Isopropyl Myristate 
Dimethicone 
Sodium Lauryl Sulfate 
Allantoin 
Sodium Metabisulfite 
Ascorbic Acid 
Propylparaben 
Edetate Disodium 
FD&C Red No. 40 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:71607-300-011 TUBE in 1 CARTON
1NDC:71607-300-5757 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A12/21/2017
Labeler - Craig Doura LLC (079084370)

 
Craig Doura LLC

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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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