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Salicylic acid - Medication Information

Product NDC Code 36800-019
Drug Name

Salicylic acid

Type Brand
Active Ingredients
Salicylic acid 40 mg/41
Route TOPICAL
Dosage Form PATCH
RxCUI drug identifier 240559
Application Number M030
Labeler Name Topco Associates LLC
Packages
Package NDC Code Description
36800-019-04 4 patch in 1 package (36800-019-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic acid 40%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
​Directions wash affected area and dry thoroughly if necessary, cut medicated patch to fit callus apply adhesive side down of medicated patch onto callus cover medicated patch with pad after 48 hours, remove medicated patch repeat procedure every 48 hours as needed for up to 14 days (until callus is removed) may soak callus in warm water for 5 minutes to assist in removal

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
​Inactive ingredients acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
​Uses for the removal of calluses relieves pain by removing calluses

Purpose

Information about the drug product’s indications for use.
​Purpose Callus remover

Spl product data elements

Usually a list of ingredients in a drug product.
Salicylic Acid Medicated Callus Removers POLYVINYL ALCOHOL VINYL ACETATE HIGH DENSITY POLYETHYLENE SALICYLIC ACID SALICYLIC ACID

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel TopCare Medicated Callus Removers SALICYLIC ACID40% Effective Callus Removal Treatment Protects Against Pressure & Friction 6 Pads | 4 Medicated Patches callus

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
​Do not use if you are a diabetic have poor blood circulation on irritated skin, on any area that is infected or reddened

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information store between 15°C to 30°C (59°F to 86°F)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
​Questions? call 1-888-423-0139

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
​Stop use and ask a doctor if discomfort persists

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
​Warnings ​For external use only. ​Do not use if you are a diabetic have poor blood circulation on irritated skin, on any area that is infected or reddened ​Stop use and ask a doctor if discomfort persists Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API