NDC 80818-246 Canafarma Spot On Acne Treatment

Salicylic Acid

NDC Product Information

Canafarma Spot On Acne Treatment with NDC 80818-246 is a a human over the counter drug product labeled by Canafarma Corp.. The generic name of Canafarma Spot On Acne Treatment is salicylic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Canafarma Corp.

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.

Canafarma Spot On Acne Treatment 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.

  • SALICYLIC ACID 20 mg/mL

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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CANNABIS SATIVA FLOWERING TOP (UNII: 8X454SZ22D)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHAMOMILE (UNII: FGL3685T2X)
  • DEANOL BITARTRATE (UNII: D240J05W14)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • FUCUS VESICULOSUS (UNII: 535G2ABX9M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LICORICE (UNII: 61ZBX54883)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • RETINOL (UNII: G2SH0XKK91)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Canafarma Corp.
Labeler Code: 80818
FDA Application Number: part333D 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 10-01-2020 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: 12-31-2021 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.

Canafarma Spot On Acne Treatment Product Label Images

Canafarma Spot On Acne Treatment 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

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses:

  • For the treatment of acne. Penetrates pores to clear most acne blemishes, acne pimples, blackheads, or whiteheads.

Warnings

For external use only

When Using This Product

  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

If Pregnant,

  • Ask a health professional before use.If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Clean the skin thoroughly before applying this productCover the entire affected area with a thin layer one to three times dailyBecause excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctorIf bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients:

Inactive ingredients: Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (European Hemp) Oil, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, DMAE Bitartrate, Dimethicone, Fucus Vesiculosus (Seaweed) Extract, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Hydrogen Peroxide, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methylisothiazolinone, Polysorbate-20, Retinol (Vitamin A),


Salix Alba (Willow) Bark Extract, Sodium Hydroxide, Sodium PCA, Sodium Pyrophosphate, Tocopheryl Acetate (Vitamin E), Xanthan Gum

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Questions?

1-800-871-7143

* Please review the disclaimer below.