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| Product NDC Code | 52000-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Universal ice cold analgesic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 866128 | ||||
| Application Number | M017 | ||||
| Labeler Name | Universal Distribution Center 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 Ingredients Menthol 1.25%
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 affected area before applying product adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1
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 relieves of minor aches and pains in muscles and joints associated with arthritis simple backache strains bruises sports injuries sprains provides cooling penetrating relief
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.Universal Ice Cold Analgesic Menthol MENTHOL, UNSPECIFIED FORM MENTHOL CAMPHOR (SYNTHETIC) BENZYL ALCOHOL BUTYLATED HYDROXYTOLUENE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) FD&C BLUE NO. 1 EDETATE DISODIUM ISOPROPYL ALCOHOL PROPYLENE GLYCOL SODIUM HYDROXIDE WATER
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 ICE COLD ANALGESIC GEL 8 FL.OZ (227 GRAM) PRINCIPAL DISPLAY PANEL
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 the reach of children If swallowed, get medical help or contact a Poison Control Center right away
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 doctor if condition worsens symptoms last more than 7 days or clean up and occur again within a few days redness or irritation develops
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 do not use in or near the eyes do not apply to wounds or damaged skin do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information store at controlled room temperature 20 to 25 o C (68 to 77 o F in a tightly closed container do not use, pour, spill or store near heat or open flame
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 Do not use with other topical pain relievers with heating pads or heating devices
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