PRAMOXINE HYDROCHLORIDE aerosol, foam

Pramoxine Hydrochloride by

Drug Labeling and Warnings

Pramoxine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Physicians Total Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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ALAVEN®
PHARMACEUTICAL LLC
Marietta, GA 30067, USA

Rev. 08/08

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146

PRINCIPAL DISPLAY PANEL - 15 g Carton

NDC: 54868-5865-0

STORE UPRIGHT

proctofoam®
non-
steroid
(pramoxine hydrochloride 1%)

hemorrhoidal foam

For temporary
relief of
hemorrhoidal
pain and itching

For External Use Only

15 g net wt (0.53 oz)

INGREDIENTS AND APPEARANCE

PRAMOXINE HYDROCHLORIDE 
pramoxine hydrochloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54868-5865(NDC: 68220-143)
Route of Administration	RECTAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54868-5865-0	1 in 1 CARTON
1		15 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	02/22/2008

Labeler - Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Business Operations
Physicians Total Care, Inc.		194123980	relabel