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| Product NDC Code | 51224-162 | ||||
|---|---|---|---|---|---|
| Drug Name | Astringent |
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| Type | Brand | ||||
| Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | POWDER, FOR SOLUTION | ||||
| RxCUI drug identifier | 1250234 | ||||
| Application Number | part347 | ||||
| Labeler Name | TAGI Pharma Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each packet) Purpose Aluminum sulfate tetradecahydrate, 1347 mg Astringent When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions . Calcium acetate monohydrate, 952 mg Astringent
| Aluminum sulfate tetradecahydrate, 1347 mg | Astringent |
| Calcium acetate monohydrate, 952 mg | Astringent |
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 dissolve 1 to 3 packets in a pint (16 oz) of cool or warm water stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.16% (1 packet), 0.32% (2 packets), or 0.48% (3 packets) aluminum acetate and is ready for use. For use as a soak: soak affected area for 15 to 30 minutes as needed, or as directed by a doctor repeat 3 times a day or as directed by a doctor discard solution after each use For use as a compress or wet dressing: soak a clean, soft cloth in the solution apply cloth loosely to affected area for 15 to 30 minutes repeat as needed or as directed by a doctor discard solution after each use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients dextrin
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 temporarily relieves minor skin irritations due to: poison ivy poison oak poison sumac insect bites athlete's foot rashes caused by soaps, detergents, cosmetics, or jewelry
Purpose
Information about the drug product’s indications for use.Active ingredients (in each packet) Purpose Aluminum sulfate tetradecahydrate, 1347 mg Astringent When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions . Calcium acetate monohydrate, 952 mg Astringent
| Aluminum sulfate tetradecahydrate, 1347 mg | Astringent |
| Calcium acetate monohydrate, 952 mg | Astringent |
Spl product data elements
Usually a list of ingredients in a drug product.Astringent Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate Calcium acetate monohydrate Calcium Cation Aluminum sulfate tetradecahydrate Aluminum Cation icodextrin
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 - 2299 mg Packet Carton NDC 51224-162-12 ALUMINUM SULFATE TETRADECAHYDRATE / CALCIUM ACETATE MONOHYDRATE ASTRINGENT SOLUTION Soothing, Effective Relief of Minor Skin Irritations due to: Poison Ivy Athlete's Foot Insect Bites Rashes Compares to the Active Ingredients in Domeboro ® tagi PHARMA 12 POWDER PACKETS Principal Display Panel - 2299 mg Packet Carton
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
Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Distributed by: TAGI Pharma South Beloit, IL 61080
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-855-225-8244
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 condition worsens or symptoms persist for more than 7 days
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. If contact occurs, rinse thoroughly with water. do not cover compress or wet dressing with plastic to prevent evaporation in some skin conditions, soaking too long may overdry
Storage and handling
Information about safe storage and handling of the drug product.Other information protect from excessive heat
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 When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. do not cover compress or wet dressing with plastic to prevent evaporation in some skin conditions, soaking too long may overdry Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days 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