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Product NDC Code | 13709-238 | ||||
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Drug Name | Neilmed hot and cold pain relief |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
RxCUI drug identifier | 1430458 | ||||
Application Number | M017 | ||||
Labeler Name | NeilMed Pharmaceuticals Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts: Active Ingredient Menthol 16.0%
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 Directions: Shake well – adults and children 12 years of age and older: spray product on affected area, not more than 3 to 4 times daily. – children under 12 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Glycerin, Propylene Glycol, SD Alcohol 40 (58%), USP grade Purified Water.
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 alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains
Purpose
Information about the drug product’s indications for use.Drug Facts: Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.NeilMed Hot and Cold Pain Relief Pain Relief Spray MENTHOL MENTHOL ALCOHOL PROPYLENE GLYCOL GLYCERIN
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.Package Label - NeilMed Hot & Cold Pain Relief NeilMed Hot & Cold Pain Relief Spray
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.Warnings: Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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. Flammable: Do not use while smoking or near heat or flames. Avoid long term storage above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. When using this product avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Use only as directed. Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional 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