Lavoclen Cream

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:

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.

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.

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.

Lavoclen-4 Creamy Wash is supplied as:

• 170.1 g (6.0 oz) tubes                                      NDC 66993-926-06
• Acne Wash Kit, containing:                              NDC 66993-928-98

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

Soap Free Cleanser Lotion 106.6 mL (3.6 Fl Oz)

Lavoclen-8 Creamy Wash is supplied as:

• 170.1 g (6.0 oz) tubes                                      NDC 66993-927-06
• Acne Wash Kit, containing:                              NDC 66993-929-98

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

Soap Free Cleanser Lotion 106.6 mL (3.6 Fl Oz)

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