Label: PROCTOFOAM HC- pramoxine hydrochloride hydrocortisone acetate aerosol, foam

Proctofoam® HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam for anal use containing hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a hydrophilic base containing cetyl alcohol, emulsifying wax, methylparaben, poly-oxyethylene-10-stearyl ether, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane.

Proctofoam® HC contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.

Hydrocortisone acetate

Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1 mg/100 mL.

Chemical name: pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-,(11β)-.

Pramoxine hydrochloride

Molecular weight: 329.86. Pramoxine hydrochloride is freely soluble in water. Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-, hydrochloride.

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pramoxine hydrochloride is a surface or local anesthetic which is not chemically related to the "caine" types of local anesthetics. Its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics.

Proctofoam® HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.

Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Do not insert any part of the aerosol container directly into the anus. Avoid contact with the eyes. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). If there is no evidence of clinical improvement within two or three weeks after starting Proctofoam® HC therapy, or if the patient's condition worsens, discontinue the drug. Keep this and all medicines out of the reach of children.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-210-5948 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantity to a tissue and rub in gently.

Directions for Use.

1.

Place cap on top of container. Shake foam container vigorously for 5-10 seconds before each use. Do not remove container cap during use of the product.

2.

Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION.

3.

Pull plunger past the fill line on the applicator barrel.

4.

Hold the container and applicator at eye level. Place the index and middle fingers on the container cap flanges and the thumb beneath the container. Support the applicator with your other hand. Prime the container by pressing down firmly on flanges and then release. With initial priming, a burst of air may come out of the container. It usually requires 1-2 pumps for foam to appear.

5.

To fill applicator barrel, press down firmly on cap flanges, hold for 1-2 seconds, and release. Wait 5-10 seconds to allow foam to expand in applicator barrel. Repeat until foam reaches fill line. It usually requires 3-4 pumps for foam to reach fill line. Remove applicator from container cap. Note: If foam goes beyond fill line, it will continue to expand and flow backwards resulting in foam build-up under cap.

6.

Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. CAUTION: Do not insert any part of the aerosol container directly into the anus. Apply to anus only with enclosed applicator. Do not insert any part of the applicator past the anus into rectum.

7.

After each use, applicator parts should be pulled apart for thorough cleaning with warm water. Since some foam will appear under the cap, the cap and underlying tip should be pulled apart and rinsed to help prevent build-up of foam and possible blockage.

Proctofoam® HC is supplied in an aerosol container with a special anal applicator. When used correctly, the aerosol container will deliver a minimum of 14 applications.

NDC 0037-6822-10     10 g

Store upright at controlled room temperature 20°-25°C (68°-77°F). DO NOT REFRIGERATE.

Distributed by:
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120
(c)2020 Mylan Specialty L.P.

Proctofoam is a registered trademark of Alaven Pharmaceutical LLC, a Mylan company.

IN-682210-03
141135-0420

PLEASE READ CAREFULLY BEFORE USING
PATIENT INSTRUCTIONS FOR   proctofoam® HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%)   TOPICAL AEROSOL Keep this insert. It contains important information about the use of proctofoam® HC.
	1  Place cap on top of container. Shake foam container vigorously for 5-10 seconds before each use. Do not remove container cap during use of the product.
	2  Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION.
	3  Pull plunger past the fill line on the applicator barrel.
	4  Hold the container and applicator at eye level. Place the index and middle fingers on the container cap flanges and the thumb beneath the container. Support the applicator with your other hand. Prime the container by pressing down firmly on flanges and then release. With initial priming, a burst of air may come out of the container. It usually requires 1-2 pumps for foam to appear.
	5  To fill applicator barrel, press down firmly on cap flanges, hold for 1-2 seconds, and release. Wait 5-10 seconds to allow foam to expand in applicator barrel. Repeat until foam reaches fill line. It usually requires 3-4 pumps for foam to reach fill line. Remove applicator from container cap. Note: If foam goes beyond fill line, it will continue to expand and flow backwards resulting in foam build-up under cap.
	6  Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. CAUTION: Do not insert any part of the aerosol container directly into the anus. Apply to anus only with enclosed applicator. Do not insert any part of the applicator past the anus into rectum.
	7  After each use, applicator parts should be pulled apart for thorough cleaning with warm water. Since some foam will appear under the cap, the cap and underlying tip should be pulled apart and rinsed to help prevent build-up of foam and possible blockage.

Distributed by:

Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

Proctofoam is a registered trademark of Alaven Pharmaceutical LLC, a Mylan company.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-210-5948 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

IS-682210-03

141134-0420

NDC 0037-6822-10
STORE UPRIGHT

proctofoam® HC

(hydrocortisone acetate 1% and
pramoxine hydrochloride 1%)
topical aerosol

Rx Only

10 g net wt

Description
proctofoam® HC (hydrocortisone acetate 1% and
pramoxine hydrochloride 1%) is a topical aerosol foam for
anal use containing hydrocortisone acetate 1% and
pramoxine hydrochloride 1% in a hydrophilic base
containing cetyl alcohol, emulsifying wax, methylparaben
polyoxyethylene-10-stearyl ether, propylene glycol
propylparaben, purified water, trolamine, and inert
propellants: isobutane and propane.

Dosage: Apply to affected areas 3 to 4 times daily. Use
the applicator supplied for anal administration. For
perianal use, transfer a small quantity to a tissue and rub
gently. See patient instructions (inside) for full
directions for use. Please see package insert for
complete prescribing information.

Caution: Do not insert any part of the aerosol container
directly into the anus. Apply to anus only with the
enclosed applicator. Do not insert any part of applicator
past the anus into rectum.

WARNINGS: Contents of the container are under
pressure. Do not burn or puncture the aerosol container.
Do not store at temperatures above 120°F (49°C).

KEEP OUT OF REACH OF CHILDREN.

Store upright at controlled room temperature

20° - 25°C (68° - 77°F).

DO NOT REFRIGERATE.

117713-0622     UC-682210-05

Distributed by:
Meda Pharmaceuticals Inc
Somerset, New Jersey

08873-4120

©2022 Viatris Inc.

PROCTOFOAM is a registered
trademark of
Alaven Pharmaceutical LLC,
a Viatris company.