AFRICAN FORMULA SKIN LIGHTENING- hydroquinone lotion

African Formula Skin Lightening by

Drug Labeling and Warnings

African Formula Skin Lightening by is a Otc medication manufactured, distributed, or labeled by International Beauty Exchange, JABONES PARDO SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydroquinone 2%

Ethylhexyl Methoxycinnamate (Octyl Methoxycinnamate) 0.5%

WARNINGS

For external use only

DO NOT USE

On children under 12 years of age unless directed by a doctor

WHEN USING

Avoid contact with eyes.

PURPOSE

Skin Lightener

INDICATIONS & USAGE

For the gradual fading of dark (brownish) areas in the skin such as freckles, age and liver spots

DOSAGE & ADMINISTRATION

Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

WATER,GLYCERYL STEARATE CITRATE, CETOSTEARYL ALCOHOL, GLYCERIN, ISOPROPYL MYRISTATE, ALLANTOIN, ASCORBIC ACID, SODIUM METABISULFITE, .ALPHA.-TOCOPHEROL ACETATE D-, SODIUM LAURYL SULFATE, EDETATE DISODIUM, METHYLPARABEN, PROPYLPARABEN, CHLOROCRESOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AFRICAN FORMULA SKIN LIGHTENING 
hydroquinone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66129-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	5 mL  in 250 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.25 mL  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
AVOCADO OIL (UNII: 6VNO72PFC1)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CHLOROCRESOL (UNII: 36W53O7109)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66129-107-11	250 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	01/01/2012

Labeler - International Beauty Exchange (966261273)

Establishment
Name	Address	ID/FEI	Business Operations
JABONES PARDO SA		462018250	manufacture