Proctofoam

Manufacturer
Alaven Pharmaceutical LLC
Effective date
2010-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:54:27

Label at a glance#

ProductProctofoam
Active ingredientpramoxine hydrochloride
Label structure12 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 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.

Storage and handling

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).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - ASK DOCTOR SECTION

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.

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-317-0001

SPL UNCLASSIFIED SECTION

ALAVEN®
PHARMACEUTICAL LLC
Marietta, GA 30067, USA

Rev. 08/08

PRINCIPAL DISPLAY PANEL - 15 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68220-143-15
STORE UPRIGHT

proctofoam®
non-
steroid

(pramoxine hydrochloride 1%)

hemorrhoidal foam

For temporary
relief of
hemorrhoidal
pain and itching

For External Use Only

ALAVEN®
PHARMACEUTICAL LLC

15 g net wt (0.53 oz)

Principal Display Panel - 15 g Carton
Principal Display Panel - 15 g Carton

PRINCIPAL DISPLAY PANEL - 15 g Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68220-143-15
For External Use Only

proctofoam® non-steroid
(pramoxine hydrochloride 1%)
hemorrhoidal foam

DIRECTIONS: Place cap on container. Shake well before use. Apply externally to affected
area up to 5 times daily. See carton for additional directions for use.
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. Certain persons can develop allergic reactions to 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. Do not use in the
eyes or nose. Do not apply to large areas of the body.
CAUTION: Do not insert any part of the aerosol container into the rectum. 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).
STORE UPRIGHT AT CONTROLLED ROOM TEMPERATURE 20° - 25°C (68° -
77°F); excursions permitted between 15° - 30°C (59° - 86°F).
DO NOT REFRIGERATE.
Keep this and all drugs out of the reach of children. In case of accidental
ingestion, seek professional assistance or contact a Poison Control Center
immediately.

ALAVEN®
PHARMACEUTICAL LLC

Marietta, GA 30067, USA
For medical inquiries, call 1-888-317-0001

15 g net weight (0.53 oz)
Rev. 05/08

Principal Display Panel - 15 g Label
Principal Display Panel - 15 g Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68220-143-15GM - Gram68220-143a0fbeb58-e5b6-431f-a62a-e67e7b05f4f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
pramoxine hydrochlorideACTIVE INGREDIENT88AYB867L51
pramoxineACTIVE MOIETY068X84E0561
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE41
isobutaneINACTIVE INGREDIENTBXR49TP6111
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
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 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68220-14368220-143-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 6 · 310 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
methylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
polyoxyl 40 stearatePOLYOXYL 40 STEARATE TYPE I13A4J4NH9ISPONGE / TOPICALNAExact identifier — unii candidate
13 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii candidate
21 equally ranked IID candidates
polyoxyl 40 stearatePOLYOXYL 40 STEARATE TYPE I13A4J4NH9ICREAM / TOPICAL86000 mgExact identifier — unii candidate
13 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii candidate
68 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
polyoxyl 40 stearatePOLYOXYL 40 STEARATE TYPE I13A4J4NH9ITABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
13 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
isobutaneISOBUTANEBXR49TP611AEROSOL, FOAM / TOPICAL18 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 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
26360995-0e1e-4721-b5f3-72e9e333af18beae280c-e321-46ea-ac1f-b7dfdf8673742010-01-14WarningsExact identifier
spl set id: beae280c-e321-46ea-ac1f-b7dfdf867374

Reported adverse events (FAERS/openFDA)#

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