NDC 69842-728 Cvs Health

Salicylic Acid

NDC Product Code 69842-728

NDC 69842-728-05

Package Description: 1 TUBE in 1 BOX > 5 g in 1 TUBE

NDC Product Information

Cvs Health with NDC 69842-728 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Cvs Health is salicylic acid. The product's dosage form is stick and is administered via topical form.

Labeler Name: Cvs Pharmacy

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Cvs Health 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 40 g/100g

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.

  • ROSIN (UNII: 88S87KL877)
  • CHLOROBUTANOL (UNII: HM4YQM8WRC)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
  • CASTOR OIL (UNII: D5340Y2I9G)

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: Cvs Pharmacy
Labeler Code: 69842
FDA Application Number: part358H 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: 02-16-2019 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: 12-31-2020 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.

Cvs Health 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

Salicylic Acid 40%

Purpose

Wart remover

Uses

  • For the removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance of the surface.For the removal of plantar warts. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.

Warnings

For external use only

Do Not Use

  • On irritated skin or on any area that is infected or reddenedon moles, birthmarks, warts with hair growing from them, genital warts, or on warts on the face or mucous membranesif you are diabeticif you have poor blood circulation

Stop Use And Ask A Doctor If

Discomfort persists

Keep Out Of Reach Of Children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • Wash affected areaMay soak in warm water for 5 minutesDry area thoroughlyApply thin layer of the product to each wartCover affected area with clean bandageRepeat procedure every 48 hours as needed (until war is removed) for up to 12 weeks

Other Information

Store at 60 - 80
oF (15 - 26
oC)

Inactive Ingredients

Beeswax, castor oil, chlorobutanol, microcrystalline wax, rosin, synthetic beeswax

* Please review the disclaimer below.

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