SKIN LIGHTENING ACCELERATOR PACK- hydroquinone kit

Skin Lightening Accelerator Pack by

Drug Labeling and Warnings

Skin Lightening Accelerator Pack by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields, LLC., Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hyrodquinone 2%                   Skin Lightener

PURPOSE

Uses

For the gradual fading of dark areas such as freckles, age and liver spots, or pigmnet in the skin that may occur in pregnancy or from the use of oral contraceptives

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Contol Center immediately

INDICATIONS & USAGE

Some users of thsi product may experience a mild skin irritation. If skin irritation becomes severs, stope use and consult a doctor

WARNINGS

Warnings

For external use only

When using this product

• Avoid contact with eyes
• do no use on children under 12 years of age unless directed by a doctor

DOSAGE & ADMINISTRATION

Directions -Skin Lightening Treatment

• Apply a genourous dime-sized amount evenly over the entire face, avoiding the eye area. Allow product to be absorbed. Do not rinse off. Use once every other day and increase to twice daily as tolerated.
• Adults: apply a small amount as a thin layer on affected areaonce or twice daily, or use as directed by a doctor. If no improvement is seen after thrre months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
• Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using the product in order to prevent darkening from reocurring
• Children under 12 years of age: do not use unless directed by a doctor

Directions -Skin Lightening Toner

• Apply evenly to the entire face with a fresh gauze pad, avoiding the eye area. Do not rinse off. Allow to dry. Use once every other day and increase to twice daily as tolerated.

• Adults: apply a small amount as a thin layer on affected areaonce or twice daily, or use as directed by a doctor. If no improvement is seen after thrre months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.

• Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using the product in order to prevent darkening from reocurringChildren under 12 years of age: do not use unless directed by a doctor

INACTIVE INGREDIENT

Skin Lightening Treatement

Water, Cetearyl Alcohol, Ethoxydiglycol, PPG-12/SMDI Copolymer, Diethylhexyl Sebacate, Polyacrylamide, Sodium C14-16 Olefin Sulfonate, Arctostaphylos Uva Ursi Leaf Extract, Glycerin, Ceteareth-20, C13-14 Isoparaffin, Dimethicone, Magnesium Ascorbyl Phosphate, Ascorbyl Palmitate, Retinol, Glycine Soja (Soybean) Oil, Glyceryl Stearate, Lactic Acid, PEG-100 Stearate, Tocopheryl Acetate, Citric Acid, Laureth-7, Sodium Metabisulfite, Imidazolidinyl Urea, Methylparaben, Propylparaben, Fragrance, Disodium EDTA, Yellow 5 (CI 19140), Yellow 6 (CI 15985)

Skin Lightening Toner

Water, Ethoxydiglycol, Hamamelis Virginiana (Witch Hazel) Water, Methylpropanediol, Polysorbate 20, Foeniculum Vulgare (Fennel) Fruit Extract, Magnesium Ascorbyl Phosphate, Arctostaphylos Uva Ursi Leaf Extract, PEG-12 Dimethicone, Arnica Montana Flower Extract, Zinc Phenolsulfonate, Kojic Acid, Citrus Medica Limonum (Lemon) Peel Extract, Salicylic Acid, Citric Acid, Sodium Sulfite, Sodijm Metabisulfite, DMDM Hydantoin, Fragrance, Sodium Hydroxide, Yellow 5 (CI 19140), Yellow 6 (CI 15985)

PRINCIPAL DISPLAY PANEL

Rodan+Fields

Reverse

Skin Lightening Accelerator Pack

For Stubborn Dark Marks and Pigmentation

Skin Lightening Toner              Skin Lightening Treatment

125 mL/4.2 Fl. Oz                     50 mL/1.7 Fl. Oz

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INGREDIENTS AND APPEARANCE

SKIN LIGHTENING ACCELERATOR PACK 
hydroquinone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-5000

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-5000-1	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKAGE	50 mL
Part 2	1 PACKAGE	125 mL

Part 1 of 2

SKIN LIGHTENING TREATMENT 
hydroquinone cream

Product Information
Item Code (Source)	NDC: 14222-5001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
DIETHYLHEXYL SEBACATE (UNII: U9LS47Q72Q)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
RETINOL (UNII: G2SH0XKK91)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LACTIC ACID (UNII: 33X04XA5AT)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAURETH-7 (UNII: Z95S6G8201)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-5001-2	1 in 1 BOX
1	NDC: 14222-5001-1	50 mL in 1 PACKAGE; 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

Part 2 of 2

SKIN LIGHTENING TONER 
hydroquinone cream

Product Information
Item Code (Source)	NDC: 14222-5002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g  in 125 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
FENNEL SEED (UNII: G3QC02NIE6)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ZINC PHENOLSULFONATE (UNII: 4O71YT5YB5)
KOJIC ACID (UNII: 6K23F1TT52)
LEMON PEEL (UNII: 72O054U628)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM SULFITE (UNII: VTK01UQK3G)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM HYDRIDE (UNII: 23J3BHR95O)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-5002-2	1 in 1 BOX
1	NDC: 14222-5002-1	125 mL in 1 PACKAGE; 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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	08/19/2015

Labeler - Rodan & Fields, LLC. (051659584)

Registrant - Cosmetic Enterprises Ltd (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd		017701475	manufacture(14222-5000, 14222-5001, 14222-5002)