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| Product NDC Code | 63736-050 | ||||
|---|---|---|---|---|---|
| Drug Name | Monistat care instant itch relief |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 360349, 1991422 |
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| Application Number | part348 | ||||
| Labeler Name | Insight Pharmaceuticals LLC | ||||
| 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 Benzocaine 20%
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 shake can well, hold 8" to 12" from affected area; spray liberally. adults and children 1 2 years and older: apply to affected area not more than 3 to 4 times daily children under 1 2 years: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Polyethylene glycol 300 Propellant: Isobutane, normal butane, propane
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 Temporary relief of pain and itching
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Monistat Care Instant Itch Relief Benzocaine BENZOCAINE BENZOCAINE POLYETHYLENE GLYCOL 300
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 MONISTAT Care 20% Benzocaine/ Tropical Analgesic MAXIMUM STRENGTH INSTANT Itch Relief SPRAY Net WT.2 OZ(57g) PRINCIPAL DISPLAY PANEL INTENSE ITCH RELIEF MONISTAT Care 20% Benzocaine/ Tropical Analgesic MAXIMUM STRENGTH INSTANT Itch Relief SPRAY Net WT.2 OZ(57g)
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.Monistat Care – Benzocaine 20% / Topical analgesic PDP Monistat Care 20 % Benzocaine / Topical analgesic Instant Itch Relief Spray NET WT. 2 OZ (57 g) Drug Facts
Other information Store at room temperature 15°– 25°C (59°– 77°F).
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 (1-800-222-1222) 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 toll free 1-877-666-4782
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 persists for more than 7 days symptoms clear up and occur again within a few 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 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 For external use only Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperatures above 49°C (120°F). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens, or symptoms persists for more than 7 days symptoms clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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