Proctosan Cream

Manufacturer
Seroyal USA | SAN’UP
Effective date
2021-07-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:14:41

Label at a glance#

ProductProctosan Cream
Active ingredientKRAMERIA LAPPACEA ROOT, COLLINSONIA CANADENSIS ROOT, PAEONIA OFFICINALIS ROOT, HORSE CHESTNUT, ACER NEGUNDO INNER BARK
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
This preparation contains:
Aesculus hippocastanum (Horse chestnut) Seeds MT 0.4%
Collinsonia canadensis (Stone root) Underground Parts MT 0.4%
Negundo (Box-elder) Bark MT 0.1%
Paeonia officinalis (Peony) Underground Parts MT 0.4%
Ratanhia (Rhatany) Root MT 2.0%

OTC - PURPOSE SECTION

Uses
For the temporary relief of symptoms associated with hemorrhoids.

WARNINGS SECTION

Warnings
For external and intrarectal use only.

Do not use this product with an applicator if the introduction of the applicator into the
rectum causes additional pain. Consult a doctor promptly.

When using this product do not exceed the recommended daily dosage unless directed by a doctor.

Stop use and ask a doctor
In case of bleeding.
If condition worsens or does not improve within 7 days.


If pregnant or breastfeeding, 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

OTHER SAFETY INFORMATION

Other information
Do not use if inner seal is missing or broken.
Store in a cool, dry place.

Contents may not fill package in order
to accommodate required labeling.
Please rely on stated quantity.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Cetostearyl alcohol, glycerin, purified water

DOSAGE & ADMINISTRATION SECTION

Directions
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 this product. Apply a small
amount on affected area in the morning and at
night and after each bowel movement, or as
recommended by your healthcare practitioner.
FOR INTRARECTAL USE: Attach applicator
to tube. Lubricate applicator well, then gently
insert applicator into the rectum. Squeeze
tube to release a small amount of cream into
the rectum. Gently remove applicator and
thoroughly cleanse applicator after each use.
Children: Use under the direction of your
healthcare practitioner.

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of symptoms associated with hemorrhoids.

Directions
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 this product. Apply a small
amount on affected area in the morning and at
night and after each bowel movement, or as
recommended by your healthcare practitioner.
FOR INTRARECTAL USE: Attach applicator
to tube. Lubricate applicator well, then gently
insert applicator into the rectum. Squeeze
tube to release a small amount of cream into
the rectum. Gently remove applicator and
thoroughly cleanse applicator after each use.
Children: Use under the direction of your
healthcare practitioner.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-3159-062106-3159-0

NDC 62106-3159-0

UNDA topicals

PROCTOSAN CREAM

Homeopathic Preparation

For the temporary relief of symptoms
associated with hemorrhoids.

Net Weight 1.4 oz (40 g)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-3159-0Proctosan Cream1 in 1 CARTONCREAM15
62106-3159-0Proctosan Cream40 g in 1 TUBECREAM405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-3159PROCTOSAN CREAM (RATANHIA, AESCULUS HIPPOCASTANUM, COLLINSONIA CANADENSIS, PAEONIA OFFICINALIS, NEGUNDO) CREAM [SEROYAL USA]5Current NDC, Legacy NDC, 2 package rows20210715_271fa97c-2aa7-5607-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-315962106-3159-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

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
Proctosan CreamRATANHIA, AESCULUS HIPPOCASTANUM, COLLINSONIA CANADENSIS, PAEONIA OFFICINALIS, NEGUNDOSeroyal USA271fa97c-2aa7-5607-e054-00144ff88e882021-07-14WarningsExact identifier
ndc (package): 62106-3159-0
ndc (product): 62106-3159
ndc11 (package): 62106315900
spl id: c71ee0b8-3c79-07b1-e053-2995a90a28de
spl set id: 271fa97c-2aa7-5607-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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