NDC 68927-3062 Caring Mill One-step Corn Removers

Salicylic Acid

NDC Product Information

Caring Mill One-step Corn Removers with NDC 68927-3062 is a a human over the counter drug product labeled by Pedifix, Inc.. The generic name of Caring Mill One-step Corn Removers is salicylic acid. The product's dosage form is strip and is administered via topical form.

Labeler Name: Pedifix, Inc.

Dosage Form: Strip - A long narrow piece of material.

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.

Caring Mill One-step Corn Removers 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 4.42 mg/1

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.

  • ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
  • BROWN IRON OXIDE (UNII: 1N032N7MFO)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

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: Pedifix, Inc.
Labeler Code: 68927
FDA Application Number: part358F 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: 01-01-2021 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 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’.

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Caring Mill One-step Corn Removers Product Label Images

Caring Mill One-step Corn Removers 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

Other

Drug Facts

Active Ingredient

Salicylic acid 40%

Purpose

Corn remover

Uses

  • For the removal of cornsRelieves pain by removing corns

Warnings

For external use only Use only as directed

Do Not Use This Product

  • On irritated skin, or on any area that is infected or reddenedIf you are diabeticIf you have poor blood circulation

Otc - Ask Doctor/Pharmacist

If discomfort persists, see your doctor or podiatrist

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control center immediately.

Directions

  • Wash affected area. Soak in warm water for 5 minutes if desired. Dry thoroughlyRemove bandages from backingApply with medicated area directly over cornAfter 48 hours, remove medicated bandageRepeat procedures every 48 hours as needed (until corn is removed) for up to 14 days

Other Information

Store between 59°and 86°F (15° and 30°C)

Inactive Ingredients

Polyvinyl Alcohol, Acrylic Copolymer

Principal Displat Panel - 12 Bandage Package

  • Caring mill™ One-Step Corn RemoversEasy, one-step applicationStays on all dayRemoves corns fastWith as few as 2 treatmentsSalicylic acid 40%12 Count

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