Proctosan Cream

Proctosan Cream is an FDA drug label for the active ingredient RATANHIA, AESCULUS HIPPOCASTANUM, COLLINSONIA CANADENSIS, PAEONIA OFFICINALIS, NEGUNDO manufactured by Seroyal USA administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20210714.

Generic: RATANHIA, AESCULUS HIPPOCASTANUM, COLLINSONIA CANADENSIS, PAEONIA OFFICINALIS, NEGUNDO

Manufacturer: Seroyal USA

Product Type: HUMAN OTC DRUG

Route: TOPICAL

Dosage Form:

NDC: 62106-3159

Application:

Effective: 20210714

Active Ingredients: 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%

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.

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.

Contraindications

Not available.

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.

Adverse Reactions

Not available.

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