NDC 72206-000 Keeva Organics Acne Treatment

Salicylic Acid

NDC Product Code 72206-000

NDC CODE: 72206-000

Proprietary Name: Keeva Organics Acne Treatment What 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: Salicylic Acid What 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

NDC Code Structure

  • 72206 - Cob Ecommerce Empire Llc

NDC 72206-000-00

Package Description: 1 BOX in 1 CARTON > 30 g in 1 BOX

NDC Product Information

Keeva Organics Acne Treatment with NDC 72206-000 is a a human over the counter drug product labeled by Cob Ecommerce Empire Llc. The generic name of Keeva Organics Acne Treatment is salicylic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cob Ecommerce Empire Llc

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.

Keeva Organics 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 100 mg/g

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)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ROSA MOSCHATA OIL (UNII: J99W255AWF)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • MILK THISTLE (UNII: U946SH95EE)
  • HOPS (UNII: 01G73H6H83)
  • SQUALENE (UNII: 7QWM220FJH)
  • ISOCETYL PALMITATE (UNII: 355356620Z)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • RACEMENTHOL (UNII: YS08XHA860)
  • HYALURONIC ACID (UNII: S270N0TRQY)

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: Cob Ecommerce Empire Llc
Labeler Code: 72206
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: 03-01-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 05-01-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Keeva Organics Acne Treatment Product Label Images

Keeva Organics 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

Proprietary Ingredients

Salicylic Acid 10% w/v

Inactive Ingredients

Deionized Water, Stearic Acid, Glyceryl Stearate, She Butter, Rosehip Seed Oil, Sesame Seed Oil, Olive Oil, Extracts of White Willows, Burdock, Milk Thistle, Hops, Sophora Root Extract, Squalene, Isooctyl Palmitate, Ispropyl Myristate, Polydimethylsiloxane, Salicylic Acid, Vitamin E, tea Tree Oil, Argan Oil, Phenoxyethanol, DL-Menthol, Hyaluronic Acid, and Grapeseed Extract.

Use

Acne treatment

Warnings

For external use only

Do Not Use

If you • have sensitive skin • are sensitive to salicylic acid

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.rinse right away with water if it gets in eyes avoid unnecessary sun exposure and use a sunscreenavoid contact with the eyes, lips and mouthavoid contact with hair and dyed fabrics, which maybe bleached by this productskin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop Use And Ask A Doctor

If skin irritation becomes severe

Keep Out Of Reach Of Children.

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 applicationaily, 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 dayif going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor,

* Please review the disclaimer below.