NDC 10157-2112 Tucks Multi-care Relief Kit (tucks Hemorrhoidal And Tucks Medicated Cooling 40 Count)

Glycerin, Lidocaine, And Witch Hazel

NDC Product Code 10157-2112

NDC Code: 10157-2112

Proprietary Name: Tucks Multi-care Relief Kit (tucks Hemorrhoidal And Tucks Medicated Cooling 40 Count) Additional informationCallout TooltipWhat 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: Glycerin, Lidocaine, And Witch Hazel Additional informationCallout TooltipWhat 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.


Code Structure
  • 10157 - Blistex Inc
    • 10157-2112 - Tucks Multi-care Relief Kit (tucks Hemorrhoidal And Tucks Medicated Cooling 40 Count)

NDC 10157-2112-1

Package Description: 1 KIT in 1 CARTON * 14 g in 1 TUBE * 1 mL in 1 APPLICATOR

NDC Product Information

Tucks Multi-care Relief Kit (tucks Hemorrhoidal And Tucks Medicated Cooling 40 Count) with NDC 10157-2112 is a a human over the counter drug product labeled by Blistex Inc. The generic name of Tucks Multi-care Relief Kit (tucks Hemorrhoidal And Tucks Medicated Cooling 40 Count) is glycerin, lidocaine, and witch hazel. The product's dosage form is kit and is administered via form.

Labeler Name: Blistex Inc

Dosage Form: Kit - A packaged collection of related material.

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.


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)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • STEARYL BEHENATE (UNII: A68S9UI39D)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • OATMEAL (UNII: 8PI54V663Y)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Blistex Inc
Labeler Code: 10157
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: 02-15-2019 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: 12-31-2019 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.

Tucks Multi-care Relief Kit (tucks Hemorrhoidal And Tucks Medicated Cooling 40 Count) Product Label Images

Tucks Multi-care Relief Kit (tucks Hemorrhoidal And Tucks Medicated Cooling 40 Count) 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

Other

Tucks® Hemorrhoidal CreamDrug Facts

Tucks® Medicated Cooling PadsDrug Facts

Otc - Purpose

Active ingredientsPurposeGlycerin 15.0% (w/w)ProtectantLidocaine 5.0% (w/w)Local anesthetic

Uses

  • Temporarily relieves the local pain, itching and discomfort associated with hemorrhoidstemporarily provides a coating for relief of anorectal discomfortstemporarily relieves rectal irritation and burning

  • Temporarily relieves the local itching and discomfort associated with hemorrhoidsaids in protecting irritated anorectal areastemporarily relieves irritation and burning

Warnings

For external use only

For external use only

When Using This Product

  • Do not exceed the recommended daily dosage unless directed to do so by a doctordo not put directly in the rectum by using fingers or any mechanical device or applicator

  • Do not use more than directed unless told to do so by a doctordo not put directly in the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • Rectal bleeding occurscondition worsens or does not improve within 7 dayscertain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

  • Rectal bleeding occurscondition worsens or does not improve within 7 days

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.

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

Directions

  • Adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently dry by patting or blotting with toilet tissue or a soft cloth before applyingapply externally to the affected area up to 6 times daily or after each bowel movementChildren under 12 years of age: ask a doctor

  • Adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently dry by patting or blotting with toilet tissue or a soft cloth before applyingapply externally to the affected area up to 6 times daily or after each bowel movementafter application, discard pad and wash handsChildren under 12 years of age: ask a doctor

Inactive Ingredients

Arachidyl alcohol, arachidyl glucoside, avena sativa kernel flour (colloidal oatmeal), behenyl alcohol, disodium EDTA, ethylhexylglycerin, microcrystalline wax, petrolatum, phenoxyethanol, polyglyceryl-3 diisostearate, polysorbate 60, purified water, sorbitan isostearate, stearyl behenate

Citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Active Ingredient

Witch hazel (50% v/v)

Purpose

Astringent

Other Information

  • For use as a moist compress — if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but not to exceed directions for use

* Please review the disclaimer below.

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