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White tetterine - Medication Information

Product NDC Code 12258-242
Drug Name

White tetterine

Type Brand
Pharm Class Azole Antifungal [EPC],
Azoles [CS]
Active Ingredients
Miconazole nitrate 2 g/100g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 998442,
998458
Application Number part333C
Labeler Name S.S.S. Company
Packages
Package NDC Code Description
12258-242-01 1 tube in 1 carton (12258-242-01) / 28.4 g in 1 tube
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient: Miconazole Nitrate 2%

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 Clean the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot pay special attention to the spaces between the toes, wear well fitting ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer consult a doctor. This product is not effective on the scalp or nails.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Other Ingredients Fragrance, paraffin wax, petrolatum, and starch

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 treats most athlete's foot, jock itch and ringworm. Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch. Relieves itchy, scaly skin between the toes or itching, burning feet associated with athlete's foot Ask your health professional regarding additional uses

Purpose

Information about the drug product’s indications for use.
Purpose: Antifungal

Spl product data elements

Usually a list of ingredients in a drug product.
White Tetterine Miconazole Nitrate PARAFFIN PETROLATUM ALUMINUM STARCH OCTENYLSUCCINATE MICONAZOLE NITRATE MICONAZOLE

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 NDC 12258-242-01 Tetterine® OINTMENT Antifungal Cures: Athlete's Foot, Jock Itch and Ringworm Net wt. 1oz. (28.4 g.) Other Packaging Content S.S.S. Company Atlanta, GA 30315 MADE IN U.S.A. Manufactured by S.S.S. Company Atlanta, GA See our online catalog at www.ssspharmaceuticals.com Rev. B Principal Display Panel

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.
DRUG FACTS Other Information store at 15°-30°C (59°-86°F). To report an adverse event or obtain product information, contact (404) 521-0857.

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 children under 2 years of age unless directed by a doctor Do not use on diaper rash For external use only

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

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 for athlete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks for jock itch if irritation occurs of if there is no improvement with-in 2 weeks

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.
When using this product Avoid contact with eyes

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 Do not use on children under 2 years of age unless directed by a doctor Do not use on diaper rash For external use only Stop use and ask a doctor if for athlete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks for jock itch if irritation occurs of if there is no improvement with-in 2 weeks When using this product Avoid contact with eyes 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