NDC 73469-0753 Scholls Wellness Company Llc One Step Corn Removers

Salicylic Acid

NDC Product Information

Scholls Wellness Company Llc One Step Corn Removers with NDC 73469-0753 is a a human over the counter drug product labeled by Scholls Wellness Company Llc. The generic name of Scholls Wellness Company Llc One Step Corn Removers is salicylic acid. The product's dosage form is disc and is administered via topical form.

Labeler Name: Scholls Wellness Company Llc

Dosage Form: Disc - A circular plate-like organ or structure.

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.

Scholls Wellness Company Llc 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 g/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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • TALC (UNII: 7SEV7J4R1U)

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: Scholls Wellness Company Llc
Labeler Code: 73469
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: 12-31-2021 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’.

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Scholls Wellness Company Llc One Step Corn Removers Product Label Images

Scholls Wellness Company Llc 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

Drug Facts

Drug Facts

Active Ingredient

Active Ingredient PurposeSalicylic Acid 40%.......................Corn remover

Purpose

Corn remover

Uses

  • Usesfor the removal of cornsrelieves pain by removing corns

Warnings

WarningsFor external use only

Do Not Use

  • Do not useif you are a diabeticif you have poor blood circulationon irritated skin or any area that is infected or reddened

Stop Use And Ask A Doctor

Stop use and ask a doctor if discomfort lasts

Keep Out Of Reach Of Children

Keep out of reach of children​. If swallowed,
get medical help or contact a Poison Control Center right away.

Directions

  • Directions​wash affected area and dry thoroughlyapply medicated bandageafter 48 hours, remove medicated bandagerepeat procedure every 48 hours as needed for up to 14 days (until corn is removed)may soak corn in warm water for 5 minutes to assist removal

Other Information

  • Other information​store between 20ºC to 25ºC (68º to 77ºF).Protect from excessive heat (temperatures above 40ºC (104ºF))

Inactive Ingredients

Inactive ingredients​ antioxidant
(CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc

Questions

Questions​? 1-866-360-3226

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