SE BPO

SE BPO- benzoyl peroxide
Seton Pharmaceuticals

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.

Rx Only.

FOR EXTERNAL USE ONLY.

DESCRIPTION

SE BPO 5.5% Cream and SE BPO 7% Wash are topical preparations containing benzoyl peroxide as the active ingredient incorporated into a Novasome® system composed of lipid vesicles.

Ingredients for SE BPO 5.5% Cream include: allantoin, aloe vera gel, butylene glycol, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, cetearyl olivate, cetyl alcohol, dimethicone, disodium EDTA, ethylene/acrylic acid copolymer, glycerin, glycine soya (soybean) sterols, methylparaben, phenoxyethanol, propylparaben, purified water, sorbitan olivate, stearyl alcohol, tocopheryl acetate, and xanthan gum.

Ingredients for SE BPO 7% Wash include: C12-C15 alkyl benzoate, cholesterol, citric acid, cocamidopropyl betaine, cocamine oxide, dimethicone, disodium laureth sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl stearate, hydrogenated castor oil, hypromellose, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, methylparaben, nonoxynol-20, octoxynol-5, PEG-6 caprylic/capric glycerides, PEG-15 pentaerythrityl tetrastearate, PEG-40 hydrogenated castor oil, poloxamer 182, purified water, sodium cocoate, and xanthan gum.

Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14 H10 O4 ) is represented by the following structure:

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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

SE BPO 5.5% Cream and SE BPO 7% Wash are indicated for use in the topical treatment of mild to moderate acne vulgaris.

CONTRAINDICATIONS

SE BPO 5.5% Cream and SE BPO 7% Wash should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.

WARNINGS

When using this product, avoid unnecessary sun exposure and use a sunscreen.

PRECAUTIONS

General:

For external use only. Avoid contact with eyes and mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy.

Information for Patients:

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING OR DISCOLORATION. If excessive irritation develops, discontinue use and consult your physician.

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

Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

OVERDOSAGE

If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

DOSAGE AND ADMINISTRATION

SE BPO 5.5% Cream and SE BPO 7% Wash should be used once or twice daily on the affected areas. Frequency of use should be adjusted to obtain the desired clinical response. If you see medication or white residue on skin after application of SE BPO 5.5% Cream, you are applying too much. Gentle cleansing of the affected areas with a mild cleanser prior to application of SE BPO 5.5% Cream may be beneficial. 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.

SE BPO 5.5% Cream: Using the foam pad applicator, apply the SE BPO 5.5% Cream by rubbing it in small circular motions on affected areas. Dispose of each applicator after single use only.

SE BPO 7% Wash: Shake well before using. Wet skin areas to be treated; apply SE BPO 7% Wash by massaging gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry.

HOW SUPPLIED

SE BPO 5.5% Cream (NDC 13925-121-30) is supplied as follows:
1 carton containing 30 packettes (0.5 grams each) of SE BPO 5.5% Cream (NDC 13925-121-05) with 30 foam pad applicators.

SE BPO 7% Wash (NDC 13925-112-18) is supplied as follows:
1 Tube (180 gram) of 7% Benzoyl Peroxide wash.

SE BPO 7-5.5 Wash KIT (NDC 13925-121-10) is supplied as follows:
1 Tube (180 gram), SE BPO 7% Wash (NDC 13925-112-18).

1 carton containing 7 packettes (0.5 gram each) of SE BPO 5.5% Cream (NDC 13925-121-05) with 7 foam pad applicators.

STORAGE

Store between 15° — 25°C (59°-77°F).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured For:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401

Seton Pharmaceuticals

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 13925-121 -10

For External Use Only

SE BPO 7-5.5 Wash Kit

7% Wash/5.5% Cream

(benzoyl peroxide)

KIT CONTAINS:
1 Tube (Net wt. 180 gram) of SE BPO 7% Wash
1 Carton Containing 7 Packettes (Net wt. 0.5 gram each)
of SE BPO 5.5% Cream with 7 Foam Pad Applicators
SETON
PHARMACEUTICALS

Carton Label
(click image for full-size original)
SE BPO
benzoyl peroxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-121
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13925-121-10 1 KIT (KIT) in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 180 g
Part 2 7 APPLICATOR 3.5 g
Part 1 of 2
SE BPO
benzoyl peroxide solution
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALKYL (C12-15) BENZOATE
CITRIC ACID MONOHYDRATE
COCAMIDOPROPYL BETAINE
DIMETHICONE
DISODIUM LAURETH SULFOSUCCINATE
EDETATE DISODIUM
GLYCERIN
GLYCERYL MONOSTEARATE
HYDROGENATED CASTOR OIL
HYPROMELLOSES
MAGNESIUM ALUMINUM SILICATE
MAGNESIUM CHLORIDE
MAGNESIUM NITRATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
METHYLPARABEN
NONOXYNOL-20
OCTOXYNOL-5
POLYOXYL 40 HYDROGENATED CASTOR OIL
POLOXAMER 182
WATER
SODIUM COCOATE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 180 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/04/2010
Part 2 of 2
SE BPO
benzoyl peroxide solution
Product Information
Route of Administration TOPICAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN
ALOE VERA LEAF
BUTYLENE GLYCOL
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
ALCOHOL
DIMETHICONE
EDETATE DISODIUM
GLYCERIN
SOY STEROL
METHYLPARABEN
PHENOXYETHANOL
PROPYLPARABEN
WATER
SORBITAN OLIVATE
STEARYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE, D-
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 7 APPLICATOR (APPLICATOR) in 1 CARTON contains a APPLICATOR
1 .5 g in 1 APPLICATOR This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/04/2010
Labeler — Seton Pharmaceuticals (828898002)
Establishment
Name Address ID/FEI Operations
IGI 011036910 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Span Packaging 557434805 PACK

Revised: 07/2011 Seton Pharmaceuticals

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