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Product NDC Code | 69574-005 | ||||
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Drug Name | Novum apr |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
RxCUI drug identifier | 1314935 | ||||
Application Number | M017 | ||||
Labeler Name | NOVUM SOLUTIONS INC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 0.5%
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 Apply this product topically to affected areas and allow to dry without rubbing. Use as often as needed. Use only as directed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients ISOPROPYL ALCOHOL, PURIFIED WATER, METHYL SALICYLATE, EUCALYPTUS ESSENTIAL OIL, SPEARMINT ESSENTIAL OIL.
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.Indications For cooling, deep-penetrating pain relief, spray Novum APR generously on the skin around aching joints or muscle pain and allow to dry without rubbing. Apply as often as needed.
Purpose
Information about the drug product’s indications for use.Purpose Pain & Itch Relief For the temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, and sprains.
Spl product data elements
Usually a list of ingredients in a drug product.NOVUM APR menthol ISOPROPYL ALCOHOL METHYL SALICYLATE EUCALYPTUS OIL SPEARMINT OIL WATER MENTHOL MENTHOL
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.Label
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 KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information External analgesic
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 Novum Solutions, Inc. 1585 West Sam Houston Pkwy N, #820 Houston, TX 77403 www.NovumSolutions.com CALL 832-200-8005 FAX 713-464-6319
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 Not intended for use on children under 2 years old except as directed by a doctor. Avoid contact with eyes. For external use only. If irritation develops and persists, discontinue use and consult a doctor. If condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.
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