NDC 21130-789 Signature Care Hemorrhoidal

Mineral Oil, Petrolatum, And Phenylephrine Hci

NDC Product Code 21130-789

NDC CODE: 21130-789

Proprietary Name: Signature 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, Petrolatum, And Phenylephrine Hci 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.

NDC Code Structure

  • 21130 - Better Living Brands, Llc

NDC 21130-789-14

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Signature Care Hemorrhoidal with NDC 21130-789 is a a human over the counter drug product labeled by Better Living Brands, Llc. The generic name of Signature Care Hemorrhoidal is mineral oil, petrolatum, and phenylephrine hci. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1372298.

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.

Signature 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)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • THYME OIL (UNII: 2UK410MY6B)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • WHITE WAX (UNII: 7G1J5DA97F)

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.

Product Labeler Information

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

Labeler Name: Better Living Brands, Llc
Labeler Code: 21130
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: 01-20-2016 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: 12-31-2022 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.

Signature Care Hemorrhoidal Product Label Images

Signature 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 HCI 0.25%..........................Vasconstrictor

Otc - Purpose

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

Warnings

WarningsFor external and/or intrarectal use only

Otc - Ask Doctor

  • Ask a doctor before use if you haveheart diseasehigh blood pressurethyroid diseasediabetesdifficulty in urination due to enlargement of the prostate glandAsk a doctor of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Otc - When Using

When using this product do not exceed the recommended daily dosage unless directed by a doctor.

Otc - Stop Use

  • Stop use and ask a doctor ifbleeding occurscondition worsens or does not improve within 7 daysintroduction of applicator into rectum causes additional pain

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional 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 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 ointment.when first opening the tube, puncture foil seal with top end of capapply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement  interacetal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into thoroughly 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 20-25°C (68-77°F)Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredientsethanol, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

Dosage & Administration

Distributed by:Better Living Brands LLCP.O. Box 99Pleasanton, CA 94566-00091-888-723-3929www.betterlivingbrandsLLC.comMade in Korea

* Please review the disclaimer below.