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| Product NDC Code | 80801-105 | ||||
|---|---|---|---|---|---|
| Drug Name | Arctic ice |
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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 | PRIMAL ELEMENTS | ||||
| 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: 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: For the temporary relief of minor muscle aches and pains. See important warnings under "When using this product" not for use on children under 2 years of age adults & children 2 years & older: Apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Blue 1, Camphor, Carbomer, Ethyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide, 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 relieves: minor muscle aches and pains
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.ARCTIC ICE MENTHOL METHYLISOTHIAZOLINONE WATER MENTHOL MENTHOL FD&C BLUE NO. 1 CAMPHOR (NATURAL) ISOPROPYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE SODIUM HYDROXIDE CARBOMER 934
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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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.Consult a doctor and discontinue use: if condition worsens, persists for more than 1 week or tends to recur.
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: heat microwave add to hot water or any container where heating water may cause splattering and result in burns use in eyes or directly on mucous membranes take by mouth or place in nostrils apply to wounds or damaged skin bandage skin
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; avoid contact with eyes. Ask a doctor before use if you have cough associated with smoking, excessive phlegm, asthma, emphysema, persistent or chronic cough.
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