NDC 72683-006 Spraypain Away

Capsaicin

NDC Product Code 72683-006

NDC 72683-006-01

Package Description: 118 g in 1 BOTTLE, SPRAY

NDC Product Information

Spraypain Away with NDC 72683-006 is a a human over the counter drug product labeled by Proximity Capital Partners Llc Dba Asutra. The generic name of Spraypain Away is capsaicin. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1116918.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Spraypain Away 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.

  • WATER (UNII: 059QF0KO0R)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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: Proximity Capital Partners Llc Dba Asutra
Labeler Code: 72683
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: 06-30-2021 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 - 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.

Spraypain Away 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 Ingredients

Capsaicin .025%

Purpose

Capsaicin .025%.............Topical Analgesic

Uses

  • Temporarily relieves minor aches and pains of muscles and joints associated with: arthritissimple backachestrainssprainsbruises

Warnings

Use only as directed. For external use only.

Otc - When Using

  • When using this product:​avoid contact with eyesdo not apply to wounds or damaged skindo not bandage tightly

Otc - Stop Use

  • Stop use and ask doctor if:condition worsenssymptoms persist for more than 7 days, or clear up and reoccur again within a few daysredness is presentirritation develops.

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 accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults over 18 years:Apply to affected area. Massage into the painful area until thoroughly absorbed. Repeat as necessary but no more than 3 to 4 times daily.Wash hands with soap and water after applying.Children 18 years and younger:Consult a doctor.

Other Information

  • Store in a cool, dry place.Keep away from excessive heat or flame.Tamper-evident for your protection. Use only if safety seal is intact.

Inactive Ingredients

Water, Magnesium Chloride, Polysorbate 20, Caprylic/Capric Triglyceride

* Please review the disclaimer below.