NDC 21130-981 Signature Care Hemorrhoidal Cream (with Applicator)

Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Glycerin, Petrolatum

NDC Product Code 21130-981

NDC CODE: 21130-981

Proprietary Name: Signature Care Hemorrhoidal Cream (with Applicator) 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: Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Glycerin, Petrolatum 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.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

  • 21130 - Better Living Brands, Llc
    • 21130-981 - Signature Care Hemorrhoidal Cream (with Applicator)

NDC 21130-981-02

Package Description: 1 TUBE, WITH APPLICATOR in 1 CARTON > 57 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Signature Care Hemorrhoidal Cream (with Applicator) with NDC 21130-981 is a a human over the counter drug product labeled by Better Living Brands, Llc. The generic name of Signature Care Hemorrhoidal Cream (with Applicator) is phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum. The product's dosage form is cream and is administered via topical form.

Labeler Name: Better Living Brands, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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 Cream (with Applicator) 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.

  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g
  • PRAMOXINE HYDROCHLORIDE 10 mg/g
  • GLYCERIN 144 mg/g
  • PETROLATUM 150 mg/g

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.

  • STEARETH-20 (UNII: L0Q8IK9E08)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • WATER (UNII: 059QF0KO0R)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LANOLIN (UNII: 7EV65EAW6H)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)

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: 01-04-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Signature Care Hemorrhoidal Cream (with Applicator) Product Label Images

Signature Care Hemorrhoidal Cream (with Applicator) 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 PurposeGlycerin 14.4%............................................................Skin protectantPhenylephrine HCl 0.25%...........................................VasconstrictorPramoxine HCl 1%......................................................Local anestheticWhite petrolatum 15%.................................................Skin protectant

Otc - Purpose

  • Usesfor temporary relief of pain, soreness and burninghelps relieve the local itching and discomfort associated with hemorrhoidstemporarily shrinks hemorrhoidal tissuetemporarily provides a coating for relief of anorectal discomfortstemporarily protects the inflamed, irritated anorectal surface to make 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 diseasedifficult in urination due to enlargement of the prostate glanddiabetes

Otc - When Using

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

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens or does not improve within 7 daysbleeding occursan allergic reaction developsthe symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

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 Center (1-800-222-1222) 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 cream.when first opening the tube, peel back foil sealapply externally or in the lower portion of the anal canal onlyapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementfor application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anusthoroughly cleanse dispensing cap after each use and replace coverchildren under 12 years of age: ask a doctor

Storage And Handling

  • Other informationstore at room temperature 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients .alpha.-tocopherol acetate, aloe vera leaf, anhydrous lanolin, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters wax, cetyl palmitate, glycryl monostearate, isopropyl myristate, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, steareth-20, stearic acid, trisodium citrate dihydrate

Dosage & Administration

Distributed by:Better Living Brands LLCMade in China

* Please review the disclaimer below.