NDC 65923-003 Family Care Hemorrhoidal

Mineral Oil

NDC Product Code 65923-003

NDC CODE: 65923-003

Proprietary Name: Family Care Hemorrhoidal What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Mineral Oil What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Mineral oil is used to treat constipation. It is known as a lubricant laxative. It works by keeping water in the stool and intestines. This helps to soften the stool and also makes it easier for stool to pass through the intestines. This medication should not be used in older adults, children younger than 6 years, or in people who are bedridden.

NDC Code Structure

  • 65923 - United Exchange Corp

NDC 65923-003-20

Package Description: 1 TUBE in 1 CARTON > 20 g in 1 TUBE

NDC Product Information

Family Care Hemorrhoidal with NDC 65923-003 is a a human over the counter drug product labeled by United Exchange Corp. The generic name of Family Care Hemorrhoidal is mineral oil. The product's dosage form is ointment and is administered via topical form.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What 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.

Family Care Hemorrhoidal Active Ingredient(s)

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


Inactive Ingredient(s)

About 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • LANOLIN (UNII: 7EV65EAW6H)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • THYME OIL (UNII: 2UK410MY6B)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • ALCOHOL (UNII: 3K9958V90M)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Administration Route(s)

What 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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: United Exchange Corp
Labeler Code: 65923
FDA Application Number: part346 What 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. What 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: 11-24-2014 What 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: 12-31-2023 What 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 - NO What 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Family Care Hemorrhoidal Product Label Images

Family Care Hemorrhoidal 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

Otc - Active Ingredient

Active ingredients                                                        PurposeMineral oil 14%.........................................................ProtectantPetrolatum 74.9%.....................................................ProtectantPhenylephrine HCl 0.25%...................................Vasoconstrictor

Otc - Purpose

  • Useshelps relieve the local itching and discomfort associated with hemorrhoidstemporarily shrinks hemorrhoidal tissue and relieve burningtemporarily provides a coating for relief of anorectal discomfortstemporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

Warnings For external use only / or intrarectal use only

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart disease
  • High blood pressurethyroid diseasedifficulty in urination due to enlargement of the prostate glanddiabetes

Otc - Ask Doctor/Pharmacist

Ask a doctor or a pharmacist before use if you are now taking a prescription drug for high blood pressure or depression

Otc - When Using

When using this product do not use more than the recommended daily dosage unless directed by a doctor

Otc - Stop Use

  • Stop use and ask a doctor ifrectal bleeding occurscondition gets worse or does not get better within 7 daysintroduction of applicator into the rectum causes additional pain

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a physician before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

  • Directionsadults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointmentwhen first opening tube, peel back foil sealapply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementintrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectumthoroughly cleanse applicator after each use and replace coveralso apply ointment to external arearegular use provides continual therapy for relief of symptomschildren under 12 years of age: ask a doctor

Storage And Handling

  • Other informationstore at 20° C to 25°C (68° to 77°F)

Inactive Ingredient

Inactive ingredients.alpha.-tocopherol acetate, alcohol, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, purified water, white wax

Dosage & Administration

Distributed by:United Exchange CorpCypress, CA 90630 USAMade in China

* Please review the disclaimer below.