Your browser does not support JavaScript! ACNE TREATMENT KIT PRESCRIPTION CARE (BENZOYL PEROXIDE) KIT [BLUE CROSS LABORATORIES]
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ACNE TREATMENT KIT PRESCRIPTION CARE (benzoyl peroxide) kit
[Blue Cross Laboratories]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 Description
1NDC:22431-112-011 in 1 KIT
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
SORBITOL 
DIMETHYL ISOSORBIDE 
CETYL ESTERS WAX 
TRIDECYL TRIMELLITATE 
TRIDECYL STEARATE 
GLYCERYL MONOSTEARATE 
CHAMAEMELUM NOBILE 
SODIUM PYRROLIDONE CARBOXYLATE 
IMIDUREA 
XANTHAN GUM 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:22431-113-01118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D11/01/2008
Part 2 of 3
RENEWING TONER 
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRGLYCOLIC ACID 
INGRALOE VERA LEAF 
INGRHAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 
INGRCHAMAEMELUM NOBILE 
INGRGLYCERIN 
INGRPROPYLENE GLYCOL 
INGRSODIUM PYRROLIDONE CARBOXYLATE 
INGRPOLYSORBATE 20 
INGRPANTHENOL 
INGRHYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
INGRALLANTOIN 
INGRIMIDUREA 
INGRMETHYLCHLOROISOTHIAZOLINONE 
INGRMETHYLISOTHIAZOLINONE 
INGRSODIUM HYDROXIDE 
INGRFD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1118 mL in 1 BOTTLE
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
DIMETHICONE 
PANTHENOL 
CYCLOMETHICONE 
ALLANTOIN 
CARBOMER 934 
METHYLPARABEN 
PROPYLPARABEN 
TROLAMINE 
DIAZOLIDINYL UREA 
POLYETHYLENE GLYCOL 4500 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:22431-114-01118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D11/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D11/01/2009
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: 02/2013
Document Id: e08f62bb-5270-47e1-869c-3dbc664723a0
Set id: 04a4a6e0-580c-484e-99b7-7019868f8f30
Version: 19
Effective Time: 20130206
 
Blue Cross Laboratories

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