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Genital wart removal onitment - Medication Information

Product NDC Code 84735-001
Drug Name

Genital wart removal onitment

Type Brand
Active Ingredients
Salicylic acid .4 g/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 251407
Application Number M028
Labeler Name Hengyang Chuangjiujia Trading Co., Ltd.
Packages
Package NDC Code Description
84735-001-01 1 tube in 1 box (84735-001-01) / 30 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
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.
Wash affected area (maysoak wart in warm waterfor 5 minutes if desired) Dry area thoroughly. Apply small amount byhand to covereach wart.Let dry. Repeat this proceduretwice dailyas needed forup to 12 weeks

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Deionized Water Hydrogen Peroxide Birch Oil Petroleum C13-14 Methyl Salicy-late Cetearyl Alcohol Mineral 0il Ceteareth-20 Sodium Lauryl Sulfate Diazolidinyl Urea EDTA Disodium Salt lodopropynyl Butylcarbamate

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.
Use For the removal ofcommon warts. Thecommon wart is easilyrecognized by the rough"cauliflower-like" appear-ance of the surface.

Purpose

Information about the drug product’s indications for use.
WART REMOVAL

Spl product data elements

Usually a list of ingredients in a drug product.
Genital wart removal onitment Salicylic acid HYDROGEN PEROXIDE BETULA PENDULA TAR OIL SALICYLIC ACID SALICYLIC ACID MINERAL OIL WATER C13-14 ISOPARAFFIN IODOPROPYNYL BUTYLCARBAMATE METHYL SALICYLATE LIQUID PETROLEUM DIAZOLIDINYL UREA EDETATE DISODIUM CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER SODIUM LAURYL SULFATE

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.
label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Genital wart removal onitment

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 on irfitatedskinor on any area that isinfected or reddened m ifyou are diabetic or if youhave poor blood circulationm piles birthmarkssm warts with hair growingfrom them

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 ofreach of children. lfswallowed, get medical helpor contact a Poison ControlCenter right away.

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 & ask a doctor ifdiscomfort persists

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
If pregnant or breastfeed-ing, ask a health profession.al before use. Keep out ofreach of children. lfswallowed, get medical helpor contact a Poison ControlCenter right away.

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.
For external use onlyIf the product gets intoeyes, flush with water for15 minutes. Avoid inhalingvapours

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