NDC 72522-100 Capsiva

Capsiva Pain Relieving Gel

NDC Product Code 72522-100

NDC 72522-100-03

Package Description: 1 TUBE in 1 CARTON > 84 g in 1 TUBE

NDC 72522-100-25

Package Description: 1 TUBE in 1 CARTON > 35 g in 1 TUBE

NDC 72522-100-33

Package Description: 1 TUBE in 1 CARTON > 9 g in 1 TUBE

NDC Product Information

Capsiva with NDC 72522-100 is a a human over the counter drug product labeled by Anesis Life, Llc. The generic name of Capsiva is capsiva pain relieving gel. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Capsiva 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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • 2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)
  • SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)
  • CUCUMBER (UNII: YY7C30VXJT)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBIC ACID (UNII: X045WJ989B)

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: Anesis Life, Llc
Labeler Code: 72522
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 06-01-2019 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: 12-31-2022 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.

Capsiva 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 6XArnica Montana L 6X

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pains associated with:• Arthritis• Muscle• Back• Joint• Burn• Sunburn• Headache

Warnings

• For external use only• Use only as directed• Avoid contact with eyes and open wounds• In case of accidental contact with eyes, immediately flush with water and seek professional help• Do not apply local heat (such as heating pads) to the area of use• Do not cover or bandage

Stop Use And Ask Physician If:

Condition worsens or persists, or a rash occurs

Directions

• Apply gel on clean skin enough to cover affected area• Apply to area of pain, as needed• Not more than 5 times a day• Adjust usage to achieve desired pain reduction• Do not use over other topical remedies• After applying, wash hands with soap and water

Inactive Ingredients

Purified Water, Aloe Barbadensis Leaf, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cucumis Sativus, Benzyl Alcohol, Salicylic Acid,Glycerin, Sorbic Acid.*These statements have not been evaluated by the US Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

* Please review the disclaimer below.