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| Product NDC Code | 71207-100 | ||||||
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| Drug Name | Tricalm hydrogel |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 1594642, 1594647 |
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| Application Number | part347 | ||||||
| Labeler Name | Modular Thermal Technologies LLC Dba Life Wear Technologies | ||||||
| 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 ingredient Aluminum acetate (0.2%)
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 Adults and children two years of age and older, apply to affected area as needed or as directed by a physician. Consult a physician for children under the age of two.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Butylene glycol, caprylyl glycol, dehydroacetic acid, ethylhexylglycerin, glycine, hexylene glycol, malic acid, phenoxyethanol, purified water, strontium chloride hexahydrate, xanthan gum.
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 temporary relief of 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.Purpose Astringent
Spl product data elements
Usually a list of ingredients in a drug product.TriCalm Hydrogel Aluminum Acetate ALUMINUM ACETATE ALUMINUM CATION BUTYLENE GLYCOL CAPRYLYL GLYCOL DEHYDROACETIC ACID ETHYLHEXYLGLYCERIN GLYCINE HEXYLENE GLYCOL MALIC ACID PHENOXYETHANOL WATER STRONTIUM CHLORIDE HEXAHYDRATE XANTHAN GUM
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 - 60 mL Vertical Carton TRICALM ® Rapid Relief From Itching, Burning & Stinging SOOTHING ITCH RELIEF HYDROGEL Steroid-Free Aluminum Acetate Astringent 2 FL OZ (60mL) PRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton
Principal Display Panel Tube TRICALM Steroid-Free Hydrogel For Itching Burning and Stinging 2.0 FLOZ ( 60mL) Principal Display Panel Tube
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
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? Call 855-TRI-CALM
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 last 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 apply to open wounds.
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 apply to open wounds. Stop use and ask a doctor if condition worsens or symptoms last 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