proctofoam® non-steroid (pramoxine hydrochloride 1%)

Drug Details [pdf]

PROCTOFOAM- pramoxine hydrochloride aerosol, foam
Alaven Pharmaceutical LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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proctofoam®
non-steroid
(pramoxine hydrochloride 1%)

Drug Facts

Active ingredient

Pramoxine hydrochloride 1%

Purpose

Local Anesthetic

Use

for the temporary relief of pain and itching associated with hemorrhoids

Warnings

Do not exceed the recommended daily dosage unless directed by a physician.

If condition worsens or does not improve within 7 days, consult a physician.

In case of rectal bleeding, consult a physician promptly.

Do not put this product into the rectum by using fingers or any mechanical device or applicator. Do not insert any part of the aerosol container into the rectum.

Certain persons can develop allergic reactions to the ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place cap on container. Shake well before use.
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or a soft cloth before application of proctofoam®.
Dispense proctofoam® onto a clean tissue and apply externally to the affected area up to 5 times daily.
Children under 12 years of age: consult a physician.

Other information

Store upright at controlled room temperature 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F).
Do not refrigerate.
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).

Inactive ingredients

cetyl alcohol, glyceryl monostearate and PEG-100 stearate blend, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane.

Questions?

1-888-317-0001

ALAVEN®
PHARMACEUTICAL LLC
Marietta, GA 30067, USA

Rev. 08/08

PRINCIPAL DISPLAY PANEL - 15 g Carton

NDC: 68220-143-15
STORE UPRIGHT

proctofoam®
non-
steroid
(pramoxine hydrochloride 1%)

hemorrhoidal foam

For temporary
relief of
hemorrhoidal
pain and itching

For External Use Only

ALAVEN®
PHARMACEUTICAL LLC

15 g net wt (0.53 oz)

PRINCIPAL DISPLAY PANEL - 15 g Label

NDC: 68220-143-15
For External Use Only

proctofoam® non-steroid
(pramoxine hydrochloride 1%)
hemorrhoidal foam

DIRECTIONS: Place cap on container. Shake well before use. Apply externally to affected
area up to 5 times daily. See carton for additional directions for use.
WARNINGS: Do not exceed the recommended daily dosage unless directed by a
physician. If condition worsens or does not improve within 7 days, consult a physician. In
case of rectal bleeding, consult a physician promptly.
Do not put this product into the rectum by using fingers or any mechanical device or
applicator. Certain persons can develop allergic reactions to ingredients in this product. If
the symptom being treated does not subside or if redness, irritation, swelling, pain or other
symptoms develop or increase, discontinue use and consult a physician. Do not use in the
eyes or nose. Do not apply to large areas of the body.
CAUTION: Do not insert any part of the aerosol container into the rectum. 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).
STORE UPRIGHT AT CONTROLLED ROOM TEMPERATURE 20° - 25°C (68° -
77°F); excursions permitted between 15° - 30°C (59° - 86°F).
DO NOT REFRIGERATE.
Keep this and all drugs out of the reach of children. In case of accidental
ingestion, seek professional assistance or contact a Poison Control Center
immediately.

ALAVEN®
PHARMACEUTICAL LLC

Marietta, GA 30067, USA
For medical inquiries, call 1-888-317-0001

15 g net weight (0.53 oz)
Rev. 05/08

PROCTOFOAM
pramoxine hydrochloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68220-143
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
pramoxine hydrochloride (UNII: 88AYB867L5) (pramoxine - UNII:068X84E056)	pramoxine hydrochloride	150 mg in 15 g

Ingredient Name	Strength
Inactive Ingredients
cetyl alcohol (UNII: 936JST6JCN)
glyceryl monostearate (UNII: 230OU9XXE4)
methylparaben (UNII: A2I8C7HI9T)
polyoxyl 40 stearate (UNII: 13A4J4NH9I)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)
isobutane (UNII: BXR49TP611)
propane (UNII: T75W9911L6)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 68220-143-15	1 in 1 CARTON	09/30/1990	12/31/2019
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	09/30/1990	12/31/2019

Labeler - Alaven Pharmaceutical LLC (140210829)

Revised: 1/2010

Document Id: 26360995-0e1e-4721-b5f3-72e9e333af18

Set id: beae280c-e321-46ea-ac1f-b7dfdf867374

Version: 2

Effective Time: 20100114

Alaven Pharmaceutical LLC