NDC 0904-6829 Major Medi-pads

Witch Hazel

NDC Product Code 0904-6829

NDC Product Information

Major Medi-pads with NDC 0904-6829 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Major Medi-pads is witch hazel. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Major Medi-pads Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • WITCH HAZEL 50 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALOE (UNII: V5VD430YW9)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: part346 Additional informationCallout TooltipWhat is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 01-25-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Major Medi-pads Product Label Images

Major Medi-pads Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Witch hazel 50%

Purpose

Astringent

Uses

  • Helps relieve the local itching and discomfort associated with hemorrhoidstemporary relief of irritation and burning.aids in protecting irritated anorectal areas.

Warnings

For external use only.

When Using This Product

  • Do not exceed the recommended daily dosage unless directed by a doctordo not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Use And Ask A Doctor If

  • Bleeding occurscondition 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.

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 doctorDispose of pad in trash after use.Do not flush

Other Information

  • Store at room temperature 15-30°C (59-86°F)

Inactive Ingredients

Water, Alcohol, Glycerin, Phenoxyethanol, Aloe, Decyl Glucoside, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Citric Acid

* Please review the disclaimer below.

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