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SYMBA Skin Lightening by Craig Doura LLC

Medically reviewed on Dec 18, 2017

Dosage form: cream
Ingredients: HYDROQUINONE 19mg in 1g
Labeler: Craig Doura LLC
NDC Code: 71607-200

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.

Warnings

For external use only

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, Papaya Extract (Carica Papaya 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 Yellow 5.

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

SYMBA®
SKIN LIGHTENING CREAM
PAPAYA

NDC 71607-200-01

With Papaya Fruit Extract, Vitamin A, and Vitamin E

SYMBA SKIN LIGHTENING 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71607-200
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 1-Stearate 
Propylene Glycol 
Papaya 
Mineral Oil 
Cetyl Palmitate 
Isopropyl Myristate 
Dimethicone 
Sodium lauryl Sulfate 
Allantoin 
Sodium Metabisulfite 
Ascorbic Acid 
Propylparaben 
Edetate Disodium 
FD&C Yellow NO. 5 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:71607-200-011 TUBE in 1 CARTON
1NDC:71607-200-5757 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A10/12/2017
Labeler - Craig Doura LLC (079084370)

 
Craig Doura LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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