SYMBA SKIN LIGHTENING- hydroquinone cream

SYMBA Skin Lightening by

Drug Labeling and Warnings

SYMBA Skin Lightening by is a Otc medication manufactured, distributed, or labeled by Craig Doura LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

SYMBA SKIN LIGHTENING 
hydroquinone cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part358A	10/12/2017

Labeler - Craig Doura LLC (079084370)