Proctosan Cream

Ratanhia, Aesculus Hippocastanum, Collinsonia Canadensis, Paeonia Officinalis, Negundo

Seroyal Usa
Human Otc Drug
NDC 62106-3159

Proctosan Cream also known as Ratanhia, Aesculus Hippocastanum, Collinsonia Canadensis, Paeonia Officinalis, Negundo is a human otc drug labeled by 'Seroyal Usa'. National Drug Code (NDC) number for Proctosan Cream is 62106-3159. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Proctosan Cream drug includes Acer Negundo Inner Bark - 1 [hp_X]/40g Collinsonia Canadensis Root - 1 [hp_X]/40g Horse Chestnut - 1 [hp_X]/40g Krameria Lappacea Root - 1 [hp_X]/40g Paeonia Officinalis Root - 1 [hp_X]/40g . The currest status of Proctosan Cream drug is Active.

Drug Information:

Drug NDC:	62106-3159
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Proctosan Cream
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Ratanhia, Aesculus Hippocastanum, Collinsonia Canadensis, Paeonia Officinalis, Negundo
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Seroyal Usa
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ACER NEGUNDO INNER BARK - 1 [hp_X]/40g COLLINSONIA CANADENSIS ROOT - 1 [hp_X]/40g HORSE CHESTNUT - 1 [hp_X]/40g KRAMERIA LAPPACEA ROOT - 1 [hp_X]/40g PAEONIA OFFICINALIS ROOT - 1 [hp_X]/40g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	17 Dec, 2015
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	21 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Seroyal USA
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	9GB215FRJX O2630F3XDR 3C18L6RJAZ P29ZH1A35Z 8R564U2E1P
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
62106-3159-0	1 TUBE in 1 CARTON (62106-3159-0) / 40 g in 1 TUBE	17 Dec, 2015	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Proctosan Cream

Ratanhia & more..

Cream
Seroyal USA
NDC: 62106-3159

Purpose:

Uses for the temporary relief of symptoms associated with hemorrhoids.

Product Elements:

Proctosan cream ratanhia, aesculus hippocastanum, collinsonia canadensis, paeonia officinalis, negundo krameria lappacea root krameria lappacea root collinsonia canadensis root collinsonia canadensis root paeonia officinalis root paeonia officinalis root horse chestnut horse chestnut acer negundo inner bark acer negundo inner bark water glycerin cetostearyl alcohol

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.

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.

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.

Overdosage:

If swallowed, get medical help or contact a poison control center right away.

Package Label 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) 62106-3159-0

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.