PROCTOSAN CREAM- ratanhia, aesculus hippocastanum, collinsonia canadensis, paeonia officinalis, negundo cream 
Seroyal USA

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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PROCTOSAN CREAM

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.

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

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.

62106-3159-0

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)

PROCTOSAN CREAM 
ratanhia, aesculus hippocastanum, collinsonia canadensis, paeonia officinalis, negundo cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-3159
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT1 [hp_X]  in 40 g
COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT1 [hp_X]  in 40 g
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P) PAEONIA OFFICINALIS ROOT1 [hp_X]  in 40 g
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT1 [hp_X]  in 40 g
ACER NEGUNDO INNER BARK (UNII: 9GB215FRJX) (ACER NEGUNDO INNER BARK - UNII:9GB215FRJX) ACER NEGUNDO INNER BARK1 [hp_X]  in 40 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62106-3159-01 in 1 CARTON12/17/2015
140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/17/2015
Labeler - Seroyal USA (018361118)
Establishment
NameAddressID/FEIBusiness Operations
SAN’UP401010287manufacture(62106-3159)

Revised: 7/2021
Document Id: c71ee0b8-3c79-07b1-e053-2995a90a28de
Set id: 271fa97c-2aa7-5607-e054-00144ff88e88
Version: 5
Effective Time: 20210714
 
Seroyal USA