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Product NDC Code | 22431-014 | ||||||
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Drug Name | Arctic ice pain relieving |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | GEL | ||||||
RxCUI drug identifier | 311502 | ||||||
Application Number | part348 | ||||||
Labeler Name | Blue Cross Laboratories, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ARCTIC ICE ANALGESIC GEL
Active Ingredient Menthol 2.0%
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 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 and children 2 years of age and older: apply 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, isopropyl alcohol, methylchoroisothiazolinone, methuylisothiazoline, 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 Temporary relief: minor muscles 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 pain relieving MENTHOL CAMPHOR (NATURAL) ALCOHOL FD&C BLUE NO. 1 ISOPROPYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE SODIUM HYDROXIDE 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.arctic ice
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Consult a doctor and discontinue use if condition worsens, persist for more than 1 week or tends to recur
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.
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 healing 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