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

Principal Display Panel - 57 g Tube Carton

SYMBA SKIN LIGHTENING
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71607-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	19 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
GlyceryL 1-Stearate (UNII: 258491E1RZ)
Propylene Glycol (UNII: 6DC9Q167V3)
Papaya (UNII: KU94FIY6JB)
Mineral Oil (UNII: T5L8T28FGP)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Dimethicone (UNII: 92RU3N3Y1O)
Sodium lauryl Sulfate (UNII: 368GB5141J)
Allantoin (UNII: 344S277G0Z)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Propylparaben (UNII: Z8IX2SC1OH)
Edetate Disodium (UNII: 7FLD91C86K)
FD&C Yellow NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71607-200-01	1 in 1 CARTON	10/12/2017
1	NDC:71607-200-57	57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part358A	10/12/2017

Labeler - Craig Doura LLC (079084370)

SYMBA Skin Lightening