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| Product NDC Code | 12258-241 | ||||
|---|---|---|---|---|---|
| Drug Name | Green tetterine |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 998442, 998458 |
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| Application Number | part333C | ||||
| Labeler Name | S.S.S. Company | ||||
| Packages |
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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 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 FD&C blue #1, 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.Green Tetterine Miconazole Nitrate FD&C BLUE NO. 1 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 12258-241-01 Tetterine® Ointment Antifungal Cures: Athlete's Foot, Jock Itch and Ringworm Net wt. 1oz. (28.4g.) Other Packaging Content Manufactured by S.S.S. Company Atlanta, GA 1-800-237-3843 www.ssspharmaceuticals.com Rev. B RETAIN THIS CARTON FOR FUTURE REFERENCE! 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 a serious adverse event or for 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 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 using 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 or 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 the 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 For external use only When using this product Avoid contact with the eyes Stop using 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 or if there is no improvement with-in 2 weeks 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