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Name:Benzoyl Peroxide 4
Manufacturer:Physicians Total Care, Inc.
Category:Prescription Marketed Drugs


BENZOYL PEROXIDE 4  - benzoyl peroxide cream 
BENZOYL PEROXIDE 8  - benzoyl peroxide cream 
Physicians Total Care, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACNE WASH FOR TOPICAL USE

Rx Only

DESCRIPTION

Lavoclen-4 Creamy Wash and Lavoclen-8 Creamy Wash are topical preparations containing benzoyl peroxide as the active ingredient. Lavoclen-4 Creamy Wash and Lavoclen-8 Creamy Wash contain: 4% and 8% benzoyl peroxide, respectively, in a lathering cream vehicle containing cetearyl alcohol, cocamidopropyl betaine, corn starch, dimethyl isosorbide, glycerin, glycolic acid, hydrogenated castor oil, imidurea, lactic acid, methylparaben, mineral oil, PEG-14M, potassium lauryl sulfate, purified water, sodium hydroxide, sodium lauryl sulfate, sodium PCA, titanium dioxide.

The structural formula of benzoyl peroxide is:

Image of structural formula

CLINICAL PHARMACOLOGY

The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne.

Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

INDICATIONS AND USAGE

Lavoclen-4 Creamy Wash and Lavoclen-8 Creamy Wash are indicated for use in the topical treatment of mild to moderate acne vulgaris. Lavoclen-4 Creamy Wash or Lavoclen-8 Creamy Wash may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.

CONTRAINDICATIONS

Lavoclen-4 Creamy Wash and Lavoclen-8 Creamy Wash should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product.

PRECAUTIONS

General - For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Carcinogenesis, Mutagenesis, Impairment of Fertility - Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.

Pregnancy: Category C - Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed.

Nursing Mothers - It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use - Safety and effectiveness in children below the age of 12 have not been established. 

ADVERSE REACTIONS

Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use.

DOSAGE AND ADMINISTRATION

Shake well before using. Wash the affected areas once a day during the first week, and twice a day therafter as tolerated. Wet skin areas to be treated; apply Lavoclen-4 Creamy Wash or Lavoclen-8 Creamy Wash, work to a full lather, rinse thoroughly and pat dry. Frequency of use should be adjusted to obtain the desired clinical response. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.

HOW SUPPLIED

Lavoclen-4 Creamy Wash is supplied as:

  • 170.1 g (6.0 oz) tubes                                      NDC 54868-5881-0

Lavoclen-4 Creamy Wash 170.1 g (6.0 oz) tube


Lavoclen-8 Creamy Wash is supplied as:

  • 170.1 g (6.0 oz) tubes                                      NDC 54868-5235-0

Lavoclen-8 Creamy Wash 170.1 g (6.0 oz) tube


Store at controlled room temperature, 15°-30°C (59°-86°F).

U.S. Patent No. 6,433,024

Manufactured for: Prasco Laboratories, Mason, OH 45040  USA

Manufactured by: Stiefel Laboratorires, Inc., Coral Gables, FL 33134

Iss. 01/09

302660


Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK        74146

Principal Display Panel

Creamy Wash

(benzoyl peroxide 4%)


Rx only

Net Wt. 170.1 g (6.0 oz)

Usual Dosage: Wash affected areas once or twice daily or as directed by physician. (See Package Insert)

Contains: Benzoyl Peroxide 4% in a cream vehicle containing Cetearyl Alcohol, Cocamidopropyl Betaine, Corn Starch, Dimethyl Isosorbide, Glycerin, Glycolic Acid, Hydrogenated Castor Oil, Imidurea, Lactic Acid, Methylparaben, Mineral Oil, PEG-14M, Potassium Lauryl Sulfate, Purified Water, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium PCA, Titanium Dioxide.

Caution: Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Store at controlled room temperature, 15o -30oC (59o – 86oF).

Expiration date and lot number on crimp.

image of benzoyl peeroxide 4% label

Principal Display Panel

Creamy Wash

(benzoyl peroxide 8%)

ACNE WASH FOR TOPICAL USE

Rx only

Net Wt. 170.1 g (6.0 oz)

Usual Dosage: Wash affected areas once or twice daily or as directed by physician. (See Package Insert)

Contains: Benzoyl Peroxide 8% in a cream vehicle containing Cetearyl Alcohol, Cocamidopropyl Betaine, Corn Starch, Dimethyl Isosorbide, Glycerin, Glycolic Acid, Hydrogenated Castor Oil, Imidurea, Lactic Acid, Methylparaben, Mineral Oil, PEG-14M, Potassium Lauryl Sulfate, Purified Water, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium PCA, Titanium Dioxide.

Caution: Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Store at controlled room temperature, 15o -30oC (59o – 86oF).

Expiration date and lot number on crimp.

image of benzoyl peroxide 8% label

BENZOYL PEROXIDE 4 
benzoyl peroxide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5881(NDC:66993-926)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 6.8 g  in 170.1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
STARCH, CORN  
DIMETHYL ISOSORBIDE  
GLYCERIN  
GLYCOLIC ACID  
HYDROGENATED CASTOR OIL  
IMIDUREA  
METHYLPARABEN  
MINERAL OIL  
WATER  
SODIUM HYDROXIDE  
SODIUM PYRROLIDONE CARBOXYLATE  
TITANIUM DIOXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5881-0 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 170.1 g in 1 TUBE This package is contained within the CARTON (54868-5881-0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/31/2008

BENZOYL PEROXIDE 8 
benzoyl peroxide cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5235(NDC:66993-927)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 13.6 g  in 170.1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
STARCH, CORN  
DIMETHYL ISOSORBIDE  
GLYCERIN  
GLYCOLIC ACID  
HYDROGENATED CASTOR OIL  
IMIDUREA  
METHYLPARABEN  
MINERAL OIL  
WATER  
SODIUM HYDROXIDE  
SODIUM PYRROLIDONE CARBOXYLATE  
TITANIUM DIOXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5235-0 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 170.1 g in 1 TUBE This package is contained within the CARTON (54868-5235-0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/07/2008

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 01/2010 Physicians Total Care, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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