ACNE TREATMENT KIT PRESCRIPTION CARE- benzoyl peroxide   
Blue Cross Laboratories

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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Acne Treatment Kit Repairing

Active Ingredients Purpose

Benzoyl Perioxide 2.5% Acne Treatment

To prevent Acne

Keep out of reach of children

For external use only

Warnings

When using this product, avoid unnecessary sun exposure and use a sunscreen. Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide. This product may cause irritation, characterized by redness, burning, itching, peeling or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation still continues, consult a doctor. Keep away from eyes, lips and mouth. This product may bleach hair or dyed fabrics. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions: Use Prescription Care 3-Step System everyday, twice a day for beautiful skin.

Inactive Ingredient

Inactive Ingredients: Water, Propylene Glycol, Ethoxydiglycol, Cetearyl Alcohol, Blyceryl Stearate, Ceteareth-20, Dimethicone, Panthenol, Fragrance, Cyclomethicone, Allantoin, Carbomer, Methylparaben, Propylparaben, Triethanol Amine, Diazolidinyl Urea, PEG-100, Stearate, Xanthan Gum




image of back label

image of front label

Prescription Care

Acne Treatment Kit

Prescription Strength Acne Formula

Acne Cleanser 4 fl.oz

Renewing Toner 4 fl. oz.

Acne Repair Lotion 4 fl. oz

ACNE TREATMENT KIT  PRESCRIPTION CARE
benzoyl peroxide kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:22431-112
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:22431-112-01 1 in 1 KIT
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 118 mL
Part 2 1 BOTTLE 118 mL
Part 3 1 BOTTLE 118 mL
Part 1 of 3
ACNE CLEANSER 
benzoyl peroxide liquid
Product Information
Item Code (Source) NDC:22431-113
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
IMIDUREA (UNII: M629807ATL)  
XANTHAN GUM (UNII: TTV12P4NEE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:22431-113-01 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 11/01/2008
Part 2 of 3
RENEWING TONER 
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR WATER (UNII: 059QF0KO0R)  
INGR GLYCOLIC ACID (UNII: 0WT12SX38S)  
INGR ALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGR HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
INGR CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
INGR GLYCERIN (UNII: PDC6A3C0OX)  
INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGR PANTHENOL (UNII: WV9CM0O67Z)  
INGR HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
INGR ALLANTOIN (UNII: 344S277G0Z)  
INGR IMIDUREA (UNII: M629807ATL)  
INGR METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
INGR METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
INGR SODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
cosmetic 11/01/2009
Part 3 of 3
ACNE REPAIR 
benzoyl peroxide lotion
Product Information
Item Code (Source) NDC:22431-114
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PANTHENOL (UNII: WV9CM0O67Z)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
ALLANTOIN (UNII: 344S277G0Z)  
CARBOMER 934 (UNII: Z135WT9208)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:22431-114-01 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 11/01/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 11/01/2009
Labeler - Blue Cross Laboratories (008298879)
Registrant - Blue Cross Laboratories (008298879)
Establishment
Name Address ID/FEI Business Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd. 530766098 manufacture(22431-112, 22431-113, 22431-114)

Revised: 12/2014
Document Id: 850a09ca-347f-443d-a947-931a6b763291
Set id: 04a4a6e0-580c-484e-99b7-7019868f8f30
Version: 22
Effective Time: 20141223
 
Blue Cross Laboratories