SKIN LIGHTENING ACCELERATOR PACK- hydroquinone 
Rodan & Fields, LLC.

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.

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Skin Lightening Accelerator Pack

Hyrodquinone 2%                   Skin Lightener

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.

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

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

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

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

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)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Box

SKIN LIGHTENING ACCELERATOR PACK 
hydroquinone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-5000
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-5000-11 in 1 KIT08/19/201509/23/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKAGE 50 mL
Part 21 PACKAGE 125 mL
Part 1 of 2
SKIN LIGHTENING TREATMENT 
hydroquinone cream
Product Information
Item Code (Source)NDC:14222-5001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-5001-21 in 1 BOX
1NDC:14222-5001-150 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A08/19/201509/23/2020
Part 2 of 2
SKIN LIGHTENING TONER 
hydroquinone cream
Product Information
Item Code (Source)NDC:14222-5002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 125 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-5002-21 in 1 BOX
1NDC:14222-5002-1125 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A08/19/201509/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A08/19/201509/23/2020
Labeler - Rodan & Fields, LLC. (051659584)

Revised: 8/2015
 
Rodan & Fields, LLC.