Proctosan Cream

Proctosan Cream
SPL v5
SPL
SPL Set ID 271fa97c-2aa7-5607-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2018-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Krameria Lappacea Root (1 [hp_X]) Collinsonia Canadensis Root Paeonia Officinalis Root Horse Chestnut Acer Negundo Inner Bark
Inactive Ingredients
Water Glycerin Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-12-17

Description

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%


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and 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.

Description

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%

Section 34088-5

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

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

Cetostearyl alcohol, glycerin, purified water

Section 51945-4

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)

Section 55105-1

Uses

For the temporary relief of symptoms associated with hemorrhoids.

Section 55106-9

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%

Section 60561-8

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.


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

Cetostearyl alcohol, glycerin, purified water

Section 51945-4 (51945-4)

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)

Section 55105-1 (55105-1)

Uses

For the temporary relief of symptoms associated with hemorrhoids.

Section 55106-9 (55106-9)

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%

Section 60561-8 (60561-8)

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.


Advanced Ingredient Data


Raw Label Data

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