Major Medi-pads
Witch Hazel
Major Pharmaceuticals
Human Otc Drug
NDC 0904-6829Major Medi-pads also known as Witch Hazel is a human otc drug labeled by 'Major Pharmaceuticals'. National Drug Code (NDC) number for Major Medi-pads is 0904-6829. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Major Medi-pads drug includes Witch Hazel - 50 g/100g . The currest status of Major Medi-pads drug is Active.
Drug Information:
| Drug NDC: | 0904-6829 |
| 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: | Major Medi-pads |
| 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: | Major Pharmaceuticals |
| 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 - 50 g/100g
|
| 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: | 25 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | Major Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 844379
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| 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 |
|---|
| 0904-6829-60 | 100 PACKET in 1 PACKAGE (0904-6829-60) / 2.9 g in 1 PACKET | 25 Jan, 2019 | 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:
Major medi-pads witch hazel water alcohol glycerin phenoxyethanol aloe decyl glucoside potassium sorbate propylene glycol sodium benzoate citric acid monohydrate 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 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 keep out of reach of children if swallowed, get medical help or contact a poison control center right away.(1-800-222-1222) if pregnant or breast-feeding ask a health professional before use.
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.
Dosage and Administration:
Directions adult: cleanse the area by gently wiping, patting or blotting. if necessary, repeat until all matter is removed from the area. apply externally to the affected area up to 6 times daily or after each bowel movement. after application, discard pad and wash hands. children under 12 years of age:consult a doctor dispose of pad in trash after use. do not flush
Stop Use:
Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days
Use in Pregnancy:
If pregnant or breast-feeding ask a health professional before use.
Package Label Principal Display Panel:
Principal display panel ndc 0904-6829-60 major medi-pads hemorrhoidal pads with witch hazel cools, soothes and helps relieve local discomfort associated with hemorrhoids convenient to use 100 pads 3.0 in dia (7.5 cm dia) compare to tucks active ingredient* * this product is not manufactured or distrbiuted by mcneil-ppc, inc., owner of registered trademark trucks label
Further Questions:
Questions or comments? (800) 616-2471