PROCTOFOAM NS- pramoxine hydrochloride aerosol, foam

PROCTOFOAM by

Drug Labeling and Warnings

PROCTOFOAM by is a Otc medication manufactured, distributed, or labeled by Meda Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pramoxine hydrochloride 1%

Purpose

Local anesthetic

Use

for the temporary relief of pain and itching associated with hemorrhoids

Warnings

For external use only

When using this product

• do not exceed the recommended daily dosage unless directed by a doctor
• 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

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens or does not improve within 7 days
• allergic reaction occurs to the ingredients in this product
• symptom being treated does not subside
• redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breast-feeding,

ask a health professional before use.

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
• dispense 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° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 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 49°C (120°F)

Inactive ingredients

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

Questions?

1-888-350-1908

 

Distributed by:
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

©2017 Meda Pharmaceuticals Inc.

PROCTOFOAM and MEDA PHARMACEUTICALS are registered trademarks of Meda AB or a related entity.

Principal Display Panel – 1%

NDC: 0037-6823-15

proctofoam® non-steroid
pramoxine hydrochloride 1%
hemorrhoidal foam

For temporary
relief of
hemorrhoidal
pain and itching

STORE
UPRIGHT

NET WT.
0.53 OZ (15 g)

INGREDIENTS AND APPEARANCE

PROCTOFOAM  NS
pramoxine hydrochloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0037-6823
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)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYLPARABEN (UNII: A2I8C7HI9T)
LAURETH-23 (UNII: N72LMW566G)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ISOBUTANE (UNII: BXR49TP611)
PROPANE (UNII: T75W9911L6)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0037-6823-15	1 in 1 CARTON	08/18/2014
1		15 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	08/18/2014

Labeler - Meda Pharmaceuticals (051229602)