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Product NDC Code | 82198-0008 | ||||
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Drug Name | Utaspray |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1875611 | ||||
Application Number | M017 | ||||
Labeler Name | Big 5 Nutrition LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Menthol 10% Methyl Salicylate 5%
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 and dry application area. Spray treatment directly onto skin and gently rub in if desired. May be used up to 10 times per day in adults and children over age 2.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients Saposhnikoviae Radix, Artemisiae Argyi Folium, Moutan Cortex, Cimicfugae Rhizoma, Sophorae Flavescentis Radix, Paeoniae Radix, Rubra Notoginseng Radixet Rhizoma, Carthami Flos, Alcohol.
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 joint and muscle aches and pains sprains and strains inflammation mild bruises
Purpose
Information about the drug product’s indications for use.Purpose External analgesic
Spl product data elements
Usually a list of ingredients in a drug product.UtaSpray Menthol and Methyl Salicylate SAPOSHNIKOVIA DIVARICATA ROOT ARTEMISIA ARGYI LEAF PAEONIA X SUFFRUTICOSA ROOT BARK ACTAEA CIMICIFUGA ROOT SOPHORA FLAVESCENS ROOT PAEONIA LACTIFLORA ROOT PANAX NOTOGINSENG ROOT SAFFLOWER ALCOHOL MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID light brown
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 label
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
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 Use only as directed Avoid contact with the eyes or mucous membranes Do not use on open wounds or irritated or broken skin Discontinue use if skin rash or irritation develops or if condition worsens Consult your doctor before use if you are pregnant or breastfeeding Keep out of reach of children Store at room temperature Shake well before use, close cap tightly after use Read all product information before use
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