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 TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-112
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22431-112-011 in 1 KIT11/01/200912/05/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 BOTTLE 118 mL
Part 31 BOTTLE 118 mL
Part 1 of 3
ACNE CLEANSER 
benzoyl peroxide liquid
Product Information
Item Code (Source)NDC:22431-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22431-113-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/01/200912/05/2016
Part 2 of 3
RENEWING TONER 
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCOLIC ACID (UNII: 0WT12SX38S)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRHAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
INGRCHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRHYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRIMIDUREA (UNII: M629807ATL)  
INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
cosmetic11/01/2009
Part 3 of 3
ACNE REPAIR 
benzoyl peroxide lotion
Product Information
Item Code (Source)NDC:22431-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22431-114-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/01/200912/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/01/200912/05/2016
Labeler - Blue Cross Laboratories (008298879)
Registrant - Blue Cross Laboratories (008298879)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(22431-112, 22431-113, 22431-114)

Revised: 6/2017
 
Blue Cross Laboratories