Vanoxide® HC Lotion
(benzoyl peroxide 5%, hydrocortisone 0.5%)
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION: Each mL of VANOXIDE® HC LOTION contains, as dispensed, 50 mg benzoyl peroxide and 5 mg hydrocortisone in a
water washable vanishing lotion of BHA/BHT, caprylic/capric triglyceride, cetyl alcohol, decyl oleate, dibasic sodium phosphate, dicalcium phosphate dihydrate, dioctyl sodium sulfosuccinate, edetic acid, hydroxyethylcellulose, methylparaben, mineral oil, monobasic
sodium phosphate, polysorbate 20, polysorbate 80, propylene glycol, propylene glycol monostearate, propylparaben, water, silica,
silicone emulsion, sodium hydroxide, stearyl heptanoate and stearyl caprylate, tetrasodium EDTA.
The structural formula for benzoyl peroxide is:
O C O O C O
CH2OH
The structural formula for hydrocortisone, chemically
11, 17, 21-Trihydroxypregn-4-ene-3, 20-dione is:
CO
CH2
H
HO
CH2
H
OH
H
H
O
CLINICAL PHARMACOLOGY: Benzoyl peroxide is an antibacterial agent which has been shown to be effective against
Propionibacterium acnes. This action is believed to be largely responsible for its usefulness. In addition, benzoyl peroxide exerts a
desquamative and keratolytic action. One study in the rhesus monkey demonstrated a percutaneous absorption of about 1.8µg per
cm2 of benzoyl peroxide or 45% of the applied dose in a 24-hour period. The absorbed benzoyl peroxide was completely converted
in the skin to benzoic acid.
Topical steroids are primarily effective because of their anti-inflammatory, antipruritic and vasoconstrictive actions.
INDICATION AND USAGE: Treatment of acne vulgaris and oily skin.
CONTRAINDICATIONS: VANOXIDE HC LOTION is contraindicated in individuals having known sensitivity to benzoyl peroxide,
hydrocortisone or any of the components of the product. Topical steroids are contraindicated in viral diseases of the skin, such as
varicella or vaccinia.
WARNINGS: If itching, redness, swelling or undue dryness occurs, discontinue use.
PRECAUTIONS: For external use only. Keep away from the eyes and mucosae. Very fair individuals should begin with a single
application at bedtime allowing overnight medication. May bleach colored fabrics.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy, Category C: Animal reproduction studies have not been conducted with VANOXIDE HC LOTION. It is not known
whether VANOXIDE HC LOTION can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
VANOXIDE HC LOTION should be given to 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 VANOXIDE HC LOTION is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.
ADVERSE REACTIONS: Irritation and contact dermatitis are the most frequent side reactions to benzoyl peroxide. 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.
DOSAGE AND ADMINISTRATION: Shake well before using. Apply a thin film 1 to 3 times daily with gentle massaging to blend with
skin, or as directed by a physician.
HOW SUPPLIED: Bottles, 25 grams net weight as dispensed. Package contains a bottle of lotion base and a BENZOYL-PAK™ vial
containing a mixture of 35% benzoyl peroxide, 64% calcium phosphate, 1% silica and dioctyl sodium sulfosuccinate. Net weight
of vial is 3.8 grams.
To the Pharmacist: At the time of dispensing, add contents of BENZOYL-PAK to the lotion in the bottle. Shake well and/or stir with
glass rod to ensure uniform dispersion. Place expiration date of three (3) months on bottle label.
NDC 11086-032-01
Caution: Federal law prohibits dispensing without prescription.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Marketed by
Summers Laboratories, Inc.
Collegeville, PA 19426
L-0032-01I-02
Manufactured for
Summers Laboratories by
EMS Contract Packaging
Hatfield, PA 19440