NDC 42903-010 Livrelief Pain Relief

Capsaicin

NDC Product Code 42903-010

NDC 42903-010-50

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE

NDC Product Information

Livrelief Pain Relief with NDC 42903-010 is a a human over the counter drug product labeled by Livcorp Inc.. The generic name of Livrelief Pain Relief is capsaicin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Livcorp Inc.

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.

Livrelief Pain Relief 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.

  • CAPSAICIN .0125 g/50g

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.

  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CREATININE (UNII: AYI8EX34EU)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • MANUKA OIL (UNII: M6QU9ZUH2X)
  • POMEGRANATE FRUIT RIND (UNII: RS999V57DU)
  • ALCOHOL (UNII: 3K9958V90M)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • EMU OIL (UNII: 344821WD61)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • PEUCEDANUM OSTRUTHIUM LEAF (UNII: 86P27YRR6Y)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • RIBES NIGRUM SEED OIL (UNII: GKE1188837)
  • RUTIN (UNII: 5G06TVY3R7)
  • SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
  • TASMANNIA LANCEOLATA FRUIT (UNII: PNT2HDL13Q)
  • TETRAHYDROPIPERINE (UNII: 8904DO502T)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CREATINE (UNII: MU72812GK0)

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.
  • 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: Livcorp Inc.
Labeler Code: 42903
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 11-01-2019 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: 12-31-2020 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.

Livrelief Pain Relief Product Label Images

Livrelief Pain Relief 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

Capsaicin 0.025%

Purpose

Capsaicin 0.025%..............Topical Analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints associated with:simple backachearthritisstrainssprains

Warnings

For external use only.Flammable: keep away from fire or flame.

Otc - Do Not Use

  • Do notapply to wounds or damaged skinbandage tightlyuse with a heating pad

Otc - When Using

  • When using this productavoid contact with eyes or mucous membranesuse only as directed

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 days or clear up and occur again within a few daysexcessive skin irritation occurs

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 immediately.

Directions

  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: consult a physician

Other Information

  • Do not use if foil seal over tube spout is missing or damagedstore in a cool, dry place

Inactive Ingredients

Alcohol, Beeswax, Black Currant (Ribes Nigrum) Seed Oil, Butylene Glycol, Caprylyl Glycol, Cetearyl Olivate, Cetyl Palmitate,

Chlorphenesin, Creatine, Creatinine, Emu Oil, Ethoxydiglycol, European Elder (Sambucus Nigra) Flower Extract, Glycerin,

Inulin Lauryl Carbamate, Isopropyl Palmitate, Lecithin, Manuka (Leptospermum Scoparium) Branch/Leaf Oil, Masterwort

(Peucedanum Ostruthium) Leaf Extract, Pomegranate (Punica Granatum) Pericarp Extract, Potassium Citrate, Rutin, Sorbitan

Olivate, Sorbitan Palmitate, Tasmanian Pepperberry (Tasmannia Lanceolata) Fruit Extract, Tetrahydropiperine, Water, Xanthan

Gum

Manufactured For Livcorp Inc.

Made in Canada

Manufactured for: Delivra Inc

347 Grays Road, Hamilton, ON L8E 2Z1

1-888-788-2320

DELIVRA™ and LivRelief™ are registered

trademarks of Delivra Inc.

www.livrelief.com

Side Panel

SPORTS & ACTIVE

PAIN RELIEF CREAM

For people suffering from aches, pains and strains of sore muscles, and tenderness, LivRelief uses Delivra's unique precision delivery system to transport active ingredients deep to the source of pain, with maximum impact.\

SPORTS & ACTIVE PAIN RELIEF CREAM

powered by the transdermal Delivery system

Delivra™

LivRelief™ contains no parabens, no SLS, no

petroleum, no propylene glycol.

* Please review the disclaimer below.