Benzaclin

Name: Benzaclin

Benzaclin Overview

Benzaclin is a prescription medication used to treat acne.

Benzaclin comes as a gel to be applied to the affected skin twice daily, in the morning and evening, 

Common side effects of Benzaclin include skin irritation, burning sensation, itching, and rash. 

What other drugs will affect benzoyl peroxide and clindamycin topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide and clindamycin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

What do I need to tell my doctor BEFORE I take BenzaClin?

  • If you have an allergy to clindamycin, benzoyl peroxide, or any other part of BenzaClin (clindamycin and benzoyl peroxide gel (90-day storage)).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have ever had any of these health problems: Very loose stools called antibiotic-associated colitis, regional enteritis, ulcerative colitis, or Crohn's disease.
  • If you are using any products that have erythromycin.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take BenzaClin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Indications and Usage for BenzaClin

BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.

Adverse Reactions

During clinical trials, the most frequently reported adverse event in the BenzaClin treatment group was dry skin (12%). The table below lists local adverse events reported by at least 1% of patients in the BenzaClin and vehicle groups.

Local Adverse Events - all causalities
in >/= 1% of patients

BenzaClin
n = 420

Vehicle
n = 168

Application site reaction

13 (3%)

1 (<1%)

Dry skin

50 (12%)

10 (6%)

Pruritus

8 (2%)

1 (<1%)

Peeling

9 (2%)

-

Erythema

6 (1%)

1 (<1%)

Sunburn

5 (1%)

-

The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.

Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported

during postmarketing use of clindamycin/benzoyl peroxide products. Because these reactions

are reported voluntarily from a population of uncertain size, it is not always possible to

reliably estimate their frequency or establish a causal relationship to drug exposure.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PRINCIPAL DISPLAY PANEL - 35 gram pump

NDC 0187-5190-35

BenzaClin®
(Clindamycin and Benzoyl Peroxide) gel 1%/5%

35 g Pump

FOR TOPICAL USE ONLY
Reconstitute with Clinda-Pak™

One 35 g Pump (after reconstitution)

Rx only

VALEANT

PRINCIPAL DISPLAY PANEL - 50 gram pump

NDC 0187-5190-50
Rx only

BenzaClin®
(Clindamycin and Benzoyl Peroxide) gel 1%/5%

FOR TOPICAL USE ONLY
Reconstitute with Clinda-Pak™

One 50 g Pump (after reconstitution)

VALEANT

BenzaClin 
clindamycin phosphate and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-5190
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg  in 1 g
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE  
DOCUSATE SODIUM  
WATER  
Packaging
# Item Code Package Description
1 NDC:0187-5190-25 1 JAR in 1 CARTON
1 25 g in 1 JAR
2 NDC:0187-5190-35 1 BOTTLE, PUMP in 1 CARTON
2 35 g in 1 BOTTLE, PUMP
3 NDC:0187-5190-50 1 BOTTLE, PUMP in 1 CARTON
3 50 g in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050756 12/21/2000
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
Name Address ID/FEI Operations
Valeant Pharmaceuticals International, Inc 245141858 MANUFACTURE(0187-5190), LABEL(0187-5190), PACK(0187-5190)
Revised: 02/2017   Valeant Pharmaceuticals North America LLC

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms include bloody or watery diarrhea, which may result if you absorb this medicine through your skin by applying too much.

What should I avoid?

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid exposure to sunlight or tanning beds. BenzaClin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using sunscreen containing PABA on the same skin treated with BenzaClin, or skin discoloration may occur.

Benzoyl peroxide can bleach hair or fabrics. Do not let this medicine come into contact with clothing, hair, or colored towels or bed linens.

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