NDC 41167-1922 Aspercreme Warming No Mess

Capsaicin

NDC Product Code 41167-1922

NDC Code: 41167-1922

Proprietary Name: Aspercreme Warming No Mess 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: Capsaicin 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
  • 41167 - Chattem, Inc.
    • 41167-1922 - Aspercreme Warming No Mess

NDC 41167-1922-0

Package Description: 1 TUBE in 1 CARTON > 70.8 g in 1 TUBE

NDC Product Information

Aspercreme Warming No Mess with NDC 41167-1922 is a a human over the counter drug product labeled by Chattem, Inc.. The generic name of Aspercreme Warming No Mess is capsaicin. The product's dosage form is gel and is administered via topical form.

Labeler Name: Chattem, Inc.

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 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.


Aspercreme Warming No Mess Active Ingredient(s)

Additional informationCallout TooltipWhat 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 .00025 g/g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Chattem, Inc.
Labeler Code: 41167
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-05-2019 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: 12-31-2020 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.

Aspercreme Warming No Mess Product Label Images

Aspercreme Warming No Mess 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

Topical analgesic

Uses

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises ■ cramps

Warnings

For external use only

When Using This Product

■ read inside of carton before using■ use only as directed. Read and follow all directions and warnings on this carton.■ avoid contact with the eyes and mucous membranes■ rare cases of serious burns have been reported with products of this type■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use■ do not apply to wounds or damaged, broken or irritated skin■ do not use at the same time as other topical analgesics■ discontinue use at least 1 hour before a bath or shower■ a transient burning sensation may occur upon application but generally disappears in several days■ if severe burning occurs, discontinue use immediately and read inside carton for important information■ do not expose the area treated with product to heat or direct sunlight■ avoid applying into skin folds

Stop Use And Ask A Doctor If

■ condition worsens■ redness is present■ irritation develops■ symptoms persist for more than 7 days or clear up and occur again within a few days■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children And Pets.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults 18 years of age and older:■ apply a thin layer to affected area■ using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed■ repeat if necessary, but no more than 3 to 4 times daily■ AFTER APPLYING, WASH HANDS WITH SOAP AND WATERchildren under 18 years of age: ask a doctor

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, citric acid, disodium EDTA, ethylhexylglycerin, glycerin, methylparaben, propylene glycol, steareth-2, steareth-21, triethanolamine, waterKeep carton as it contains important information.

* Please review the disclaimer below.

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