PROCTOFOAM NS- pramoxine hydrochloride aerosol, foam 
Meda Pharmaceuticals Inc.

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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

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

© 2021 Viatris Inc.

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

Principal Display Panel – 1%

NDC 0037-6823-15

TAMPER EVIDENT FEATURE: Do not use if Meda Pharmaceuticals® seal on ends of carton are broken or missing.

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)

Proctofoam Hydrochloride Foam Carton Label
PROCTOFOAM  NS
pramoxine hydrochloride aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0037-6823
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE150 mg  in 15 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0037-6823-151 in 1 CARTON08/18/2014
115 g in 1 CANISTER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM34608/18/2014
Labeler - Meda Pharmaceuticals Inc. (051229602)

Revised: 7/2018
Document Id: fd00efca-7161-4ddc-80f4-e89bc31062ac
Set id: cddc8d81-21b8-11e4-8c21-0800200c9a66
Version: 4
Effective Time: 20180727
 
Meda Pharmaceuticals Inc.