FDA.reportPublic FDA data

PROCTOFOAM

Manufacturer
Viatris Specialty LLC
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:11:55

Label at a glance#

ProductPROCTOFOAM NS
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

• 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Local anesthetic

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching associated with hemorrhoids

Warnings

WARNINGS SECTION

For external use only

When using this product

SPL UNCLASSIFIED SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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,

SPL UNCLASSIFIED SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-350-1908

 

Distributed by:
Meda Pharmaceuticals Inc.
Canonsburg, PA 15317 U.S.A.

© 2025 Viatris Inc.

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

Principal Display Panel – 1%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Drug Facts

Active ingredient    Purpose
Pramoxine hydrochloride 1%. . . . . . . . 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

Drug Facts (continued)

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)

Drug Facts (continued)

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®
Canonsburg, PA 15317 U.S.A.
©2025 Viatris Inc.

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

117789
UC-82315-15-05

Proctofoam Hydrochloride Foam Carton Label
Proctofoam Hydrochloride Foam Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
828365pramoxine HCl 1 % Rectal FoamPSN6
828367proctofoam 1 % Rectal FoamPSN6
828367pramoxine hydrochloride 10 MG/ML Rectal Foam [Proctofoam]SBD6
828365pramoxine hydrochloride 10 MG/ML Rectal FoamSCD6
828365pramoxine hydrochloride 1 % Rectal FoamSY6
828367Proctofoam 1 % Rectal FoamSY6
828367Proctofoam 10 MG/ML Rectal FoamSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0037-6823-152024-01-30C16284748780-11030e365-48bb-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0037-6823-15PROCTOFOAMNS1 in 1 CARTONAEROSOL, FOAM16
0037-6823-15PROCTOFOAMNS15 g in 1 CANISTERAEROSOL, FOAM156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-6823-15GM - Gram0037-6823e55a2ac9-3b4e-40ad-8b56-94218dd0fce312014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L51
PRAMOXINEACTIVE MOIETY068X84E0561
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
ISOBUTANEINACTIVE INGREDIENTBXR49TP6111
LAURETH-23INACTIVE INGREDIENTN72LMW566G1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9I1
PROPANEINACTIVE INGREDIENTT75W9911L61
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0037-68230037-6823-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
METHYLPARABENA2I8C7HI9TIACT
LAURETH-23N72LMW566GIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ISOBUTANEBXR49TP611IACT
PROPANET75W9911L6IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii+dosage form
10 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii+dosage form
10 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9IAEROSOL, FOAM / TOPICAL2.83 %w/wExact identifier — unii+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii+dosage form
8 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii+route
8 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / VAGINAL100 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii+route
8 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, FOAM / RECTAL142 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii+route
10 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9IAEROSOL, FOAM / TOPICAL2.83 %w/wExact identifier — unii+dosage form
2 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GAEROSOL, FOAM / TOPICAL1.08 %w/wExact identifier — unii+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii+route
8 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii+route
6 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii+route
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii candidate
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii+dosage form
10 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / VAGINAL100 mgExact identifier — unii candidate
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii+route
10 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii+route
10 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii+route
10 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, FOAM / RECTAL142 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii+dosage form
10 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / RECTAL9 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii+dosage form
8 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii+route
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii+route
10 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii candidate
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / RECTAL9 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GAEROSOL, FOAM / TOPICAL1.08 %w/wExact identifier — unii+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii+route
10 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii+route
8 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROCTOFOAM NSPRAMOXINE HYDROCHLORIDEViatris Specialty LLCcddc8d81-21b8-11e4-8c21-0800200c9a662025-08-15WarningsExact identifier
ndc (package): 0037-6823-15
ndc (product): 0037-6823
ndc11 (package): 00037682315
spl id: 146e02e7-5477-4730-bdb1-be005dc57c4f
spl set id: cddc8d81-21b8-11e4-8c21-0800200c9a66

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.