Equate Hemorrhoidal Medicated Wipes
Witch Hazel
Wal-mart Stores, Inc.
Human Otc Drug
NDC 49035-793Equate Hemorrhoidal Medicated Wipes also known as Witch Hazel is a human otc drug labeled by 'Wal-mart Stores, Inc.'. National Drug Code (NDC) number for Equate Hemorrhoidal Medicated Wipes is 49035-793. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Equate Hemorrhoidal Medicated Wipes drug includes Witch Hazel - .5 mg/mL . The currest status of Equate Hemorrhoidal Medicated Wipes drug is Active.
Drug Information:
| Drug NDC: | 49035-793 |
| 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: | Equate Hemorrhoidal Medicated Wipes |
| 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: | Witch Hazel |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wal-mart Stores, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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: | WITCH HAZEL - .5 mg/mL
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 01 Jan, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 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. |
| Application Number: | part346 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Wal-Mart Stores, Inc.
|
| 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: | 101I4J0U34
|
| 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 |
|---|
| 49035-793-41 | 48 CONTAINER in 1 CONTAINER (49035-793-41) / 252 mL in 1 CONTAINER | 01 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. |
Purpose:
Purpose astringent
Product Elements:
Equate hemorrhoidal medicated wipes witch hazel water glycerin propylene glycol sodium citrate citric acid monohydrate iodopropynyl butylcarbamate disodium cocoamphodiacetate bronopol aloe vera leaf peg-75 lanolin witch hazel witch hazel
Indications and Usage:
Uses helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning aids in protecting irritated anorectal areas
Warnings:
Warnings for external use only
When Using:
When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days
Dosage and Administration:
Directions adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. if necessary, repeat until all matter is removed from the area use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard children under 12 years of age: consult a doctor
Stop Use:
Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days
Package Label Principal Display Panel:
Principal display panel - lid label compare to preparation h (r) medicated wipes active ingredient* 2oa694sli ndc 49035-793-41 equate flushable hemorrhoidal medicated wipes witch hazel, 50% gentle, everyday cleansing to reduce irritation cools, soothes and comforts convenient, easy to use flush safe 48 medicated wipes with aloe 5 in x 6 in (12.7 cm x 15.2 cm) flowrap1 lid1 label flowrap1 lid1
Further Questions:
For comments or questions please distributed by: wal-mart stores, inc. bentonville, ar 72716 (c) wal-mart stores, inc. *this product is not manufactured or distributed by pfizer consumer healthcare, owner of the registered trademark preparation h (r) . satisfaction guaranteed - or we'll replace it or give you your money back. for questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915