The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Proctosan Cream (NDC 62106-3159). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, overdosage, other safety information, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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%
Uses
For the temporary relief of symptoms associated with hemorrhoids.
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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Other information
Do not use if inner seal is missing or broken.
Store in a cool, dry place.
Inactive ingredients
Cetostearyl alcohol, glycerin, purified water
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.
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.
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)
* Please review the disclaimer below.
