Bencort Lotion

Name: Bencort Lotion

To the pharmacist

At the time of dispensing, add the contents of the
Bencort Benzoyl Peroxide Powder vial to the Bencort Lotion in the bottle.
Shake well to ensure uniform dispersion. Place expiration date of three (3) months on
the label. Bencort Lotion is 25 grams net weight.

Adverse Reactions

The most frequent adverse reactions to benzoyl peroxide
are irritation and contact dermatitis. Although 0.5% hydrocortisone is considered
safe, the following adverse reactions have been reported with topical corticosteroids,
especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis,
hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic
contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae,
miliaria.

This is not a complete list of possible adverse effects. If you notice other effects not
listed above, contact your doctor or pharmacist.

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

Bencort Lotion Description

Bencort Lotion (benzoyl peroxide 5% and hydrocortisone 0.5%)
TOPICAL LOTION. Each gram contains, as dispensed, 50 mg benzoyl peroxide and 5 mg
hydrocortisone.Inactive Ingredients: acetylated lanolin alcohol, BHA, C12-15 alkyl
benzoate, cetyl acetate, cetyl alcohol, citric acid, decyl oleate, dioctyl sodium
sulfosuccinate, EDTA, elaeis guineensis (palm) fruit extract, glycine soja (soybean) seed
extract, hydroxyethylcellulose, lanolin oil, methylparaben, mineral oil, oleyl acetate,
oryzanol, pentasodium pentetate, polysorbate 20, PPG-5-ceteth-20, propyl gallate,
propylene glycol, propylene glycol stearate, propylparaben, purified water (aqua), silica,
simethicone, sodium phosphate, stearyl acetate, stearyl heptanoate, tetrasodium EDTA,
tricalcium phosphate, trisodium phosphate.

The structural formula for benzoyl peroxide (Mol. Formula: C14H10O4; Mol. Weight
242.23):

The structural formula for hydrocortisone, pregn-4-ene-3,20-dione, 11,17,21-
trihydroxy-,(11b)- (Mol. Formula: C21H30O5; Mol. Weight 362.47 ):


Bencort Lotion - Clinical Pharmacology

Benzoyl peroxide is an antibacterial agent shown
to be effective against P. acnes. The antibacterial action of benzoyl peroxide is believed
to be due to the release of reactive oxygen species. Benzoyl peroxide has a keratolytic
effect which may contribute to its efficacy. Benzoyl peroxide has been shown to be
absorbed by the skin where it is converted into benzoic acid.

Hydrocortisone shares the actions of other topical corticosteroids and are used for their
anti-inflammatory and vasoconstrictive actions.

Packaging

Rx Only
NDC: 68032-419-92

Bencort Lotion Kit
(benzoyl peroxide 5% and hydrocortisone 0.5%)

Kit Contains:
•    Becort Lotion 25g (as dispensed)
•    Benzoyl Peroxide 35% Powder (to be added to the Bencort Lotion)
•    Bencort Glycerin Cleansing Lotion 60g
•    Product Information

Combined NEW WT 85g (3 oz.)

Indications: An aid in the treatment of acne.

DOSAGE AND ADMINISTRATION: Shake well before use. Apply a thin film 1 to 3 times daily, gently messaging into skin or as directed by a physician.

TO THE PHARMACIST: At the time of dispensing, add the contents of the Bencort Benzoyl Powder vial to the Bencort Hydrocortisone Lotion in the bottle. Shake well to ensure uniform dispersion. Place expiration date of three (3) months on the label. Bencort Lotion is 25g net weight, as dispensed.

Caution: Federal law prohibits dispensing without a prescription.

•    Keep away from eyes. FOR TOPICAL USE ONLY. Not for ophthalmic, oral, or intravaginal use.
•    Keep out of reach of children
•    Keep bottle tightly closed.
•    Store at room temperature 20-25C (68-77F). Do not freeze.

Consult package insert for complete prescribing information.

Apply with caution to the neck and/or other sensitive areas. There may be a slight transitory stinging or burning sensation on initial applications. Colored or dyed garments and linens may be bleached by the benzoyl peroxide.

If irritation or sensitivity occurs, discontinue use and consult your physician.

Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Iss. 10/09

BENCORT 
Bencort Lotion kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-419
Packaging
# Item Code Package Description
1 NDC:68032-419-92 1 KIT (CARTON) in 1 KIT
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 3.8 g
Part 2 1 TUBE 25 g
Part 1 of 2
BENCORT 
benzoyl peroxide powder powder
Product Information
Item Code (Source) NDC:68032-303
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 35   in 3.8 g
Packaging
# Item Code Package Description
1 NDC:68032-303-21 3.8 g in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2009
Part 2 of 2
BENCORT 
benzoyl peroxide 5% and hydrocortisone 0.5% lotion lotion
Product Information
Item Code (Source) NDC:68032-303
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 5   in 25 g
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 0.5   in 25 g
Packaging
# Item Code Package Description
1 NDC:68032-303-11 25 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2009
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2009   River's Edge Pharmaceuticals, LLC

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad skin irritation.
  • Skin changes (pimples, stretch marks, slow healing, hair growth).
  • Burning.
  • Swelling.
  • Change in color of skin.
(web3)