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NDC 00037-6823-15 PROCTOFOAM 150 mg/15g Details

PROCTOFOAM 150 mg/15g

PROCTOFOAM is a RECTAL AEROSOL, FOAM in the HUMAN OTC DRUG category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 00037-6823-15
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	00037-6823
Product ID	0037-6823_67f367b7-f7e8-466d-bd32-3e799d522aaf
Associated GPIs	89200030103905
GCN Sequence Number	062043
GCN Sequence Number Description	pramoxine HCl FOAM 1 % TOPICAL
HIC3	Q3D
HIC3 Description	HEMORRHOIDAL PREPARATIONS
GCN	97827
HICL Sequence Number	002977
HICL Sequence Number Description	PRAMOXINE HCL
Brand/Generic	Brand
Proprietary Name	PROCTOFOAM
Proprietary Name Suffix	NS
Non-Proprietary Name	pramoxine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, FOAM
Route	RECTAL
Active Ingredient Strength	150
Active Ingredient Units	mg/15g
Substance Name	PRAMOXINE HYDROCHLORIDE
Labeler Name	Meda Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00037-6823-15 (00037682315)

Pricing Information	N/A
NDC Package Code	0037-6823-15
Billing NDC	00037682315
Package	1 CANISTER in 1 CARTON (0037-6823-15) / 15 g in 1 CANISTER
Marketing Start Date	2014-08-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cddc8d81-21b8-11e4-8c21-0800200c9a66 Details

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

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)

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

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)
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	08/18/2014

Labeler - Meda Pharmaceuticals (051229602)

Revised: 7/2018

Document Id: 67f367b7-f7e8-466d-bd32-3e799d522aaf

Set id: cddc8d81-21b8-11e4-8c21-0800200c9a66

Version: 3

Effective Time: 20180727