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

Proctosan Cream by

Drug Labeling and Warnings

Proctosan Cream by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN’UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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%

PURPOSE

Uses
For the temporary relief of symptoms associated with hemorrhoids.

WARNINGS

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

Keep out of reach of children.

OVERDOSAGE

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.

INACTIVE INGREDIENT

Inactive ingredients
Cetostearyl alcohol, glycerin, purified water

DOSAGE & ADMINISTRATION

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

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.

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-3159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z)	KRAMERIA LAPPACEA ROOT	1 [hp_X]  in 40 g
COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR)	COLLINSONIA CANADENSIS ROOT	1 [hp_X]  in 40 g
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P)	PAEONIA OFFICINALIS ROOT	1 [hp_X]  in 40 g
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	1 [hp_X]  in 40 g
ACER NEGUNDO INNER BARK (UNII: 9GB215FRJX) (ACER NEGUNDO INNER BARK - UNII:9GB215FRJX)	ACER NEGUNDO INNER BARK	1 [hp_X]  in 40 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-3159-0	1 in 1 CARTON	12/17/2015
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/17/2015

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN’UP		401010287	manufacture(62106-3159)